Primary objective: To evaluate the pharmacokinetic (PK) characteristics of a single oral dose of vemurafenib tablets (240 mg/tablet) and zobovo® (reference formulation) (240 mg/tablet) in healthy participants, administered on an empty stomach or after a meal. Secondary objective: To evaluate the safety of the two formulations administered orally on an empty stomach or after a meal in healthy participants.

Start Date19 Mar 2026

Sponsor / Collaborator

Shanghai Kechow Pharma, Inc.

CTR20253233

/ CompletedNot Applicable

维莫非尼片在健康受试者中单中心、随机、开放、单剂量、两周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of vemurafenib tablets in healthy subjects under fasting and fed conditions

主要目的：评价健康受试者空腹/餐后单次口服维莫非尼片（240 mg/片）和佐博伏®（参比制剂）（240 mg/片）的药代动力学（PK）行为，评价两种制剂的生物等效性。次要目的：评价健康受试者空腹/餐后口服两种制剂的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) behavior of vemurafenib tablets (240 mg/tablet) and Zelboraf® (reference formulation) (240 mg/tablet) after single oral administration on an empty stomach or after a meal in healthy volunteers, and to assess the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the two formulations after oral administration on an empty stomach or after a meal in healthy volunteers.

Start Date28 Aug 2025

Sponsor / Collaborator

Shanghai Kechow Pharma, Inc.

100 Clinical Results associated with Vemurafenib

100 Translational Medicine associated with Vemurafenib

100 Patents (Medical) associated with Vemurafenib

3,184

Literatures (Medical) associated with Vemurafenib

31 Dec 2026·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Structure-activity relationship of Cu(II) and Pd(II) thiosemicarbazone complexes with anticancer and antibacterial properties

Article

Author: Czylkowska, Agnieszka ; Kordialik-Bogacka, Edyta ; Korga-Plewko, Agnieszka ; Kubik, Joanna ; Iwan, Magdalena ; Ścieszka, Sylwia ; Świątkowski, Marcin ; Sierański, Tomasz ; Rogalewicz, Bartłomiej ; Boruta, Tomasz ; Humeniuk, Ewelina ; Pitucha, Monika ; Kubicki, Jakub ; Michalczuk, Mariola

Twelve thiosemicarbazones and 24 corresponding Cu(II) and Pd(II) complexes were synthesised and evaluated for their physicochemical properties and biological activities. Single-crystal X-ray diffraction and mass spectrometry confirmed ligand deprotonation and the formation of neutral ML₂-type complexes. Several complexes containing 3,4-dimethoxybenzylidene- or 4-bromobenzylidene-substituted ligands exhibited submicromolar cytotoxicity against melanoma cells. Cu(b-TSC)₂ and Pd(dm-TSC-pCl)₂ were selected for mechanistic studies and induced cell-cycle arrest, pro-apoptotic gene activation, DNA damage, and apoptosis. Notably, Cu(b-TSC)₂ retained activity against vemurafenib-resistant SK-MEL-28 and A-375 cells. Structure-activity analysis showed that additional chlorine substitution generally reduced anticancer activity. Calculated physicochemical descriptors suggested that increased chlorination enhanced lipophilicity and reduced hydrophilicity, which was associated with lower apparent solution stability. These findings highlight the importance of balancing lipophilicity, hydrophilicity, and solution stability in future design of potential drugs based on thiosemicarbazones. In contrast, antibacterial activity was more strain-dependent, with MIC values against E. coli as low as 3.125 mg/L.

01 Dec 2026·Asian journal of neurosurgery

Erdheim–Chester Disease Mimicking as Multiple Meningioma—A Case Report with Review of Literature

Article

Author: Taori, Manish ; Mantry, Krishna Rekha ; Chandrakar, Naman ; Rathore, Lavlesh ; Sahu, Rajiv K. ; Agrawal, Garima

Abstract:

Erdheim–Chester disease (ECD) is a rare non-Langerhans cell systemic histiocytosis affecting multiple organs, more commonly long bones, lungs, heart and less commonly brain. Meningeal involvement is extremely rare, and till now only six cases have been detected. Our patient presented with multiple supra- and infratentorial enhancing meningeal mass lesions disguised as multiple meningiomas. The mass lesion causing the mass effect was excised, and its histopathology showed histiocytosis. Multisystemic evaluation and molecular studies confirmed the diagnosis of ECD, and the patient was started on systemic vemurafenib.

01 Nov 2026·BIOORGANIC & MEDICINAL CHEMISTRY

Novel benzofuran–1,3,4-thiadiazole aryl urea hybrids as dual VEGFR-2/BRAF inhibitors: anticancer activity, apoptosis induction, and molecular modeling studies

Article

Author: Ghabbour, Hazem A ; Abdel-Aziz, Alaa A-M ; El-Azab, Adel S ; Hamdi, Abdelrahman ; Ewes, Wafaa A ; Takla, Fiby N ; Elnagar, Mohamed R ; Serag, Marwa I ; El-Shafey, Hamed W ; Brogi, Simone

The development of dual-directed anticancer agents has emerged as an effective strategy to simultaneously modulate tumor proliferation and angiogenesis while overcoming resistance associated with single-target therapies. In the present study, a novel series of benzofuran-based aryl urea derivatives incorporating a 1,3,4-thiadiazole linker were designed as dual VEGFR-2/BRAF^WT inhibitors using sorafenib as a pharmacophoric template. The in vitro cytotoxic activity of the synthesized compounds against cervix HeLa, prostate PC-3, colon HCT-116, and breast MCF-7 cancer cell lines was evaluated. Most derivatives showed variable activity, with 5-bromobenzofuran analogues displaying superior potency. Compound 7j emerged as the most active analogue, with IC₅₀ values of 7.83-13.27 μM and reduced toxicity toward normal lung fibroblast WI-38 cells. Enzymatic assays revealed potent dual inhibition of VEGFR-2 and BRAF^WT by 7j (IC₅₀ = 0.044 and 0.071 μM, respectively), outperforming sorafenib and vemurafenib. Mechanistic studies showed that 7j induced G2/M cell cycle arrest and promoted apoptosis in HeLa cells. This effect was associated with upregulation of BAX, p53, and caspase-9, downregulation of Bcl-2, and activation of the intrinsic apoptotic pathway. Additionally, in silico studies including molecular docking and molecular dynamics simulations demonstrated stable ligand-target interactions and favorable binding modes of 7j across both VEGFR-2 and BRAF, supporting the proposed hybrid design strategy. Overall, compound 7j represents a promising dual VEGFR-2/BRAF^WT inhibitor and highlights benzofuran-based scaffolds as valuable platforms for anticancer drug development.

News (Medical) associated with Vemurafenib

19 Oct 2026

·www.biospace.com

Genentech to Present Pivotal Data at ESMO 2026, Showcasing Advances Across Its Lung and Breast Cancer Late-Stage Portfolio

Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors, in previously treated advanced G12C-mutated non-small cell lung cancer Patient-reported outcomes from Phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer Second Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3 targeted ADC, to deliver robust efficacy with a favorable safety pro high-unmet-need solid tumors SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- $RHHBY --Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from October 23 to 27 in Madrid. “Our presentations at ESMO 2026 highlight the depth and impact of Genentech’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer.” Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC Genentech will share Phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer. Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors. Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium. Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer Genentech will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective estrogen receptor degrader (SERD) and full antagonist, in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early stage (I-III). Key presentations from early-stage to advanced disease include: Patient-reported outcomes from the Phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life. Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting. Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer. Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan) New data will also be presented for Tam-Peli, an investigational next-generation B7-H3-targeted ADC designed to deliver high-potency anti-tumor activity while limiting off-target toxicity. Tam-Peli is currently being investigated across multiple solid tumor indications: ESMO data include late-breaking interim Phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumors from Phase I/II studies, and Phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC. These findings build on the TAISHAN-302 Phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis. Roche is developing and commercializing Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumor types. Overview of key presentations featuring Genentech medicines and molecules: Medicine or molecule Abstract title Abstract number/ presentation details Lung cancer Divarasib Krascendo 1: Efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC. #LBA5 Proffered Paper Session Presidential Symposium II Sunday 10.25.2026 16:30 - 16:42 CET Divarasib Krascendo 3: A randomized, Phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer. #2551 TiP Poster NSCLC, Early-Stage Monday 10.26.2026 12:00 – 12:45 CET Tam-Peli Tambotatug pelitecan (YL201): Efficacy and safety in locally advanced/ metastatic NSCLC from a Phase I study. #2577 Poster NSCLC, Locally Advanced Monday 10.26.2026 12:00 – 12:45 CET Non-specific Immunogenomic signature associated with ICI-related pneumonitis in non-small-cell lung cancer (NSCLC) patients. #4247 Rapid Oral Basic Science and Translational Research Sunday 10.25.2026 09:14 - 09:19 CET Breast cancer Giredestrant Patient (pt)-reported outcomes (PROs) from the Phase III lidERA Breast Cancer (BC) trial of giredestrant (GIRE) in pts with estrogen receptor-positive, HER2-negative early BC (ER+, HER2− eBC). #538 Rapid Oral Breast Cancer, Early-Stage Friday 10.23.2026 16:20 – 16:25 CEST Giredestrant Retrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A Phase III trial of giredestrant (GIRE) + everolimus (E) in patients with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2− aBC) in the post-CDK4/6 inhibitor (I) setting. #2 Rapid Oral Breast Cancer, Advanced Stage Saturday 10.24.2026 10:20 – 10:25 CEST Giredestrant Updated interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS Breast Cancer (BC): A Phase Ib/II study of GIRE treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2− LA/mBC). #23 Poster Advanced Breast Cancer, Other Saturday 10.24.2026 12:00 – 12:45 CEST Pertuzumab Real-world eligibility for DESTINY-Breast11 (DB-11) neoadjuvant escalation criteria and outcomes of DB-11-eligible vs DB-11-ineligible patients with HER2-positive early breast cancer (HER2+ eBC). #594 Poster Breast Cancer, Early-Stage Saturday 10.24.2026 12:00 – 12:45 CEST ZN-1041 BREnnA: Phase II/III randomized study of ZN-A-1041 or tucatinib (TUC), in combination with trastuzumab + capecitabine (HX), in patients with HER2-positive locally advanced or metastatic breast cancer (HER2+LA/mBC) with or without central nervous system (CNS) metastases. #1796 TiP Poster HER2+ Breast Cancer Saturday 10.24.2026 12:00 – 12:45 CEST Solid tumors Tam-Peli Tambotatug pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumors from Phase I/II studies. #1057 Poster Developmental Therapeutics Friday 10.23.2026 15:15 – 16:00 CEST YL211 (cMET ADC) Phase I First-in-Human (FIH) Results of YL211, a c-Met targeting Antibody-Drug Conjugate (ADC), in patients (pts) with advanced solid tumors. #1017 Poster Developmental Therapeutics Friday 10.23.2026 15:15 – 16:00 CEST Tam-Peli Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, Phase III study (TAISHAN-301). #LBA43 Proffered Paper Session Head and Neck Cancer Sunday 10.25.2026 08:40 - 08:50 CET Tecentriq (atezolizumab) + Avastin (bevacizumab) Outcomes by baseline tumor burden using 6-and-12 scores and the up-to-7 criteria in TALENTACE: Phase III study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo/Bev) or on demand TACE alone in patients with systemically untreated, unresectable hepatocellular carcinoma (uHCC). #1700 ePoster Hepatocellular Carcinoma Tecentriq (atezolizumab) ATOMIC (A021502/AIO-KRK-0317): Presentation and outcomes in patients (pts) with stage III d-MMR early-onset colon cancer (EOCC) and average-onset colon cancer (AOCC). #858 Poster Colon Cancer Sunday 10.25.2026 12:00 - 12:45 CET Tecentriq (atezolizumab) Adjuvant atezolizumab in patients with MSI-high/MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy: the Phase II ANTONIO-study (AIO-KRK-0220). #802 Poster Colon Cancer Sunday 10.25.2026 12:00 - 12:45 CET What is Itovebi? Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha ( PIK3CA ) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. It is not known if Itovebi is safe and effective in children. Important Safety Information What are the possible side effects of Itovebi? Itovebi may cause serious side effects, including: High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including: difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth: pain swelling redness ulcers Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea. Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects. The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include: decreased white blood cell counts, red blood cell counts, and platelet counts decreased blood levels of calcium, potassium, sodium, and magnesium increased creatinine blood levels tiredness increased blood levels of the liver enzyme alanine transaminase (ALT) nausea rash loss of appetite COVID-19 infection headache Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or . You may also report side effects to Genentech at (877) 436-3683. Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes or high blood sugar have kidney problems are pregnant or plan to become pregnant. Itovebi can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi. You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi. Males with female partners who are able to become pregnant: You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit . What are Tecentriq and Tecentriq Hybreza? Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer: to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and your cancer tests positive for “PD-L1”. Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer: has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you. Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma: has spread to other parts of the body or cannot be removed by surgery. Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more) . Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine: to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR). It is not known if Tecentriq Hybreza is safe and effective when used: in children younger than 12 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: in children younger than 2 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza. What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects. Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a st Contacts Media Contact: Stella Belonwu, (650) 467-6800 Advocacy Contact: Catherine Creme Henry, (202) 258-8828 Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, +41 61 68-75284 Read full story here

Clinical ResultPhase 3Phase 1ASCOADC

09 Oct 2026

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FDA Approves Genentech’s Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for the Adjuvant Treatment of a Certain Type of Stage III Colon Cancer

FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years Approval marks the twelfth indication for Tecentriq in the U.S. SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- $RHHBY --Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq ® (atezolizumab) and Tecentriq Hybreza ® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. This approval marks the twelfth indication for Tecentriq in the U.S. “This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.” “Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.” The FDA approval is based on the landmark Phase III ATOMIC study, recently published in The New England Journal of Medicine . ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA ® MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety pro consistent with previous studies of Tecentriq and mFOLFOX6. Colon cancer remains one of the world's most common and deadliest tumors. Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III. Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years. Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumors, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy. About the ATOMIC study ATOMIC (A021502, NCT02912559 ) is a Phase III, randomized, open-label, multicenter study investigating the addition of Tecentriq ® (atezolizumab) to mFOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomized 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS). The global study in the U.S. was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany. About Tecentriq ® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. What are Tecentriq and Tecentriq Hybreza? Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer: to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and your cancer tests positive for “PD-L1”. Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer: has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you. Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma: has spread to other parts of the body or cannot be removed by surgery. Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more) . Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine: to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR). It is not known if Tecentriq Hybreza is safe and effective when used: in children younger than 12 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: in children younger than 2 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza. What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects. Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza. You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq Hybreza when used alone include: feeling tired or weak muscle or bone pain cough shortness of breath decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include: high blood pressure feeling tired or weak too much protein in the urine The most common side effects of Tecentriq and Tecentriq Hybreza when used in melanoma with cobimetinib and vemurafenib include: skin rash joint, muscle, or bone pain feeling tired or weak liver injury fever nausea itching swelling of legs or arms mouth swelling (sometimes with sores) low thyroid hormone levels sunburn or sun sensitivity The most common side effects of Tecentriq and Tecentriq Hybreza when used in colon cancer with chemotherapy include: feeling tired or weak nausea numbness, tingling, or pain in the hands or feet (neuropathy) constipation cough or shortness of breath fever stomach-area (abdominal) pain diarrhea decreased appetite mouth sores (stomatitis) change in sense of taste The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is: urinary tract infection Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza. You may report side effects to the FDA at 1-800-FDA-1088 or . You may also report side effects to Genentech at 1-888-835-2555. Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information. About Genentech in Oncology For more than 30 years, Genentech has pioneered oncology breakthroughs and is working to build a future where people with cancer can thrive, in spite of their diagnosis. With our therapies, we are intercepting disease where there is potential to deliver the best outcomes, while striving for longer-term impact in hard-to-treat settings. Our therapies are designed for the real world—reducing treatment burden and ensuring innovative care reaches patients who need them most, wherever they are. By working in lockstep with the medical, scientific, and patient communities, we are shaping the next era of cancer care. About Genentech Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit . Contacts Media Contact: Stella Belonwu (650) 467-6800 Advocacy Contact: Mychalleah Werner (650) 296-6218 Investor Contacts: Loren Kalm (650) 225-3217 Bruno Eschli +41 61 687 5284

Clinical ResultPhase 3ImmunotherapyDrug Approval

08 Oct 2026

·www.gene.com

FDA Approves Genentech’s Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for The Adjuvant Treatment of a Certain Type of Stage III Colon Cancer

Thursday, Oct 8, 2026 FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years Approval marks the twelfth indication for Tecentriq in the U.S. South San Francisco, CA -- October 8, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. This approval marks the twelfth indication for Tecentriq in the U.S. “This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.” “Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.” The FDA approval is based on the landmark Phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6. Colon cancer remains one of the world's most common and deadliest tumors. Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III. Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years. Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumors, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy. About the ATOMIC study ATOMIC (A021502, NCT02912559) is a Phase III, randomized, open-label, multicenter study investigating the addition of Tecentriq® (atezolizumab) to mFOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomized 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS). The global study in the U.S. was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany. About Tecentriq® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. What are Tecentriq and Tecentriq Hybreza? Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer: to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and your cancer tests positive for “PD-L1”. Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer: has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you. Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma: has spread to other parts of the body or cannot be removed by surgery. Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more). Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine: to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR). It is not known if Tecentriq Hybreza is safe and effective when used: in children younger than 12 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: in children younger than 2 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza. What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects. Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza. You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq Hybreza when used alone include: feeling tired or weak muscle or bone pain cough shortness of breath decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include: high blood pressure feeling tired or weak too much protein in the urine The most common side effects of Tecentriq and Tecentriq Hybreza when used in melanoma with cobimetinib and vemurafenib include: skin rash joint, muscle, or bone pain feeling tired or weak liver injury fever nausea itching swelling of legs or arms mouth swelling (sometimes with sores) low thyroid hormone levels sunburn or sun sensitivity The most common side effects of Tecentriq and Tecentriq Hybreza when used in colon cancer with chemotherapy include: feeling tired or weak nausea numbness, tingling, or pain in the hands or feet (neuropathy) constipation cough or shortness of breath fever stomach-area (abdominal) pain diarrhea decreased appetite mouth sores (stomatitis) change in sense of taste The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is: urinary tract infection Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555. Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information. About Genentech in Oncology For more than 30 years, Genentech has pioneered oncology breakthroughs and is working to build a future where people with cancer can thrive, in spite of their diagnosis. With our therapies, we are intercepting disease where there is potential to deliver the best outcomes, while striving for longer-term impact in hard-to-treat settings. Our therapies are designed for the real world—reducing treatment burden and ensuring innovative care reaches patients who need them most, wherever they are. By working in lockstep with the medical, scientific, and patient communities, we are shaping the next era of cancer care. About Genentech Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. ###

Clinical ResultPhase 3ImmunotherapyDrug Approval

100 Deals associated with Vemurafenib

External Link

KEGG	Wiki	ATC	Drug Bank
D09996	Vemurafenib	L01EC01	DB08881

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
BRAF mutation positive Melanoma	Japan	Chugai Pharmaceutical Co., Ltd.	26 Dec 2014
BRAF V600 mutation-positive Melanoma	European Union	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Iceland	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Liechtenstein	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Norway	Roche Registration GmbH	17 Feb 2012
Melanoma	United States	Hoffmann-La Roche, Inc.	17 Aug 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
BRAF V600E mutant Colorectal Cancer	Phase 3	China	Shanghai Kechow Pharma, Inc.	25 Oct 2023
Anaplastic Thyroid Carcinoma	Phase 3	United Kingdom	-	01 Mar 2023
BRAF V600 mutation-positive Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	01 Mar 2023
Erdheim-Chester Disease	Phase 3	United Kingdom	-	01 Mar 2023
Glioma	Phase 3	United Kingdom	-	01 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Laryngeal Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Multiple Myeloma	Phase 3	United Kingdom	-	01 Mar 2023
Non-Small Cell Lung Cancer	Phase 3	United Kingdom	-	01 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04341181 (ProTarget, ESMO2026)	Phase 2	BRAF mutation Solid Tumors BRAF V600E	25	Vemurafenib and cobimetinib	fiiwjuphtp(rqkcqizkrc) = gxpbxfgmio wjybrwsosv (jmlitaxyyw ) View more	Positive	23 Oct 2026
EANO2026	Not Applicable	Astrocytoma First line BRAF V600E	18	Radiochemotherapy with concurrent and adjuvant temozolomide (TMZ)	dkmnykrknm(qvgvdocmsl) = fdzomkawbi jfuitsjego (vvvbrbibrr ) View more	Positive	24 Sep 2026
NCT03224767 (ALLIANCE A071601 \| CTNI-30, CTgov)	Phase 2	Craniopharyngioma \| BRAF V600E mutation-positive low grade glioma	24	cobimetinib+vemurafenib (Arm A)	vwwejmyoqi = zlwaygmmwk zqsipsmaoq (axzigkaaqd, vqimxwxqnu - nukglewwsk) View more	-	10 Jun 2026
				cobimetinib+vemurafenib (Arm B)	vwwejmyoqi = jhdflatjwo zqsipsmaoq (axzigkaaqd, ognxfpyvyf - ipxkwalvmb) View more
ASCO2026	Not Applicable	BRAF V600E Mutation-Positive Melanoma First line BRAF-mutant	790	Dabrafenib + trametinib (D+T)	vulncdefgz(mxfxhbyass) = tavcqnbngj cqjnljbezt (zbpmgsibwm, 7.33 - 9.33) View more	Positive	29 May 2026
				encorafenib + binimetinib (E+B)	vulncdefgz(mxfxhbyass) = amubpiyplh cqjnljbezt (zbpmgsibwm, 7.95 - 12.42) View more
NCT02968303 (COWBOY, ASCO2026)	Phase 2	BRAF V600E Mutation-Positive Melanoma BRAF V600E/K mutation	71	Vemurafenib 960 mg bid + Cobimetinib 60 mg QD + Vemurafenib 960 mg bidk +Cobimetinib 60 mg QD3wk	sjxxcnmjpz(tddqhqqlvv) = In arm A, the BOR was partial response (PR) in 75% of the pts (36.1% had an ongoing response after treatment switch), stable disease (SD) in 22.2%, and progressive disease (PD) in 2.8%. In arm B, 54.3% had PR, 22.9% SD, and 20% PD (1 pt was not evaluable). ybxjnawveh (wolbwsimvd ) View more	Negative	29 May 2026
				Ipilimumab 3 mg/kg q3wk + Nivolumab 1 mg/kg q3wk
NCT03554083 (NeoACTIVATE, ASCO2026)	Phase 2	Melanoma Neoadjuvant BRAF status	30	atezolizumab, vemurafenib, cobimetinib (BRAF-mutated)	gzudsiskbx(kzimqvvugb) = dayrurcwuq thdfghhlsm (uugjemnsmy, 48 - 86.3) View more	Positive	29 May 2026
EHA2026	Phase 2	Hairy Cell Leukemia	19	Vemurafenib+Cobimetinib	elidmhbxsl(mwinfufybd) = hesqhdrnkg nvmzhxqtpj (firixbdpqb ) View more	Positive	12 May 2026
				Vemurafenib+Cobimetinib (V+C+O)	elidmhbxsl(mwinfufybd) = wiofxbpzek nvmzhxqtpj (firixbdpqb ) View more
EHA2026	Not Applicable	Histiocytosis, Non-Langerhans-Cell \| Histiocytosis, Langerhans-Cell	5	Cytarabine	dwvcjayujc(yqqrraftry) = bjqaxcykyd uyuvbcxlzm (xrkksoasot ) View more	Positive	12 May 2026
				Vemurafenib	oftshigrnz(hsumnnfvyx) = gslqgnlcwp fdvsqhtlwi (qrmwbezzha )
NCT03554083 (NeoACTIVATE \| NeoACTIVATE arm C, CTgov)	Phase 2	Melanoma, Cutaneous Malignant	64	Atezolizumab+Tiragolumab	aommytrplt(vithdcxlrm) = rnfzcgbvid dgskiacdhd (mkhuvqtbhl, zwjngsjptj - vfymzlkzpn) View more	-	04 May 2026
NCT05068752 (Pubmed \| J Immunother Precis Oncol)	Phase 2	KRAS Mutant Pancreatic Cancer KRAS mutations	9	Vemurafenib and Sorafenib combination	gsrgdgwxxh(kaeoghutaz) = omaupmxqdi ztlccfhxda (goobvnmmwh ) View more	Negative	10 Feb 2026

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