RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC23H21Cl2FN6O2

InChIKeyCOWBUPJEEDYWKD-UHFFFAOYSA-N

CAS Registry1865733-40-9

Clinical Trials associated with Capmatinib Hydrochloride

CTR20252206

/ CompletedNot Applicable

盐酸卡马替尼片餐后人体生物等效性研究

[Translation] Study on the bioequivalence of capmatinib hydrochloride tablets in healthy volunteers after meals

以原研公司Novartis Pharma Schweiz AG持证的盐酸卡马替尼片（商品名：妥瑞达®，规格：200mg）为参比制剂，以齐鲁制药有限公司生产的盐酸卡马替尼片（规格：200mg）为受试制剂，按有关生物等效性试验的规定，进行人体生物等效性试验，评估餐后状态下口服两种制剂的生物等效性和安全性。

[Translation]

Using the capmatinib hydrochloride tablets (trade name: Toureda®, specification: 200 mg) certified by the original research company Novartis Pharma Schweiz AG as the reference preparation and the capmatinib hydrochloride tablets (specification: 200 mg) produced by Qilu Pharmaceutical Co., Ltd. as the test preparation, a human bioequivalence study was conducted in accordance with the relevant provisions of bioequivalence tests to evaluate the bioequivalence and safety of the two preparations when taken orally in the fed state.

Start Date13 Jun 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20251951

/ CompletedNot Applicable

盐酸卡马替尼片空腹人体生物等效性研究

[Translation] Study on the bioequivalence of capmatinib hydrochloride tablets in fasting volunteers

以原研公司Novartis Pharma Schweiz AG持证的盐酸卡马替尼片（商品名：妥瑞达®，规格：200mg）为参比制剂，以齐鲁制药有限公司生产的盐酸卡马替尼片（规格：200mg）为受试制剂，按有关生物等效性试验的规定，进行人体生物等效性试验，评估空腹状态下口服两种制剂的生物等效性和安全性。

[Translation]

Using the capmatinib hydrochloride tablets (trade name: Toureda®, specification: 200 mg) certified by the original research company Novartis Pharma Schweiz AG as the reference preparation, and the capmatinib hydrochloride tablets (specification: 200 mg) produced by Qilu Pharmaceutical Co., Ltd. as the test preparation, a human bioequivalence study was conducted in accordance with the relevant provisions of bioequivalence tests to evaluate the bioequivalence and safety of the two preparations when taken orally in the fasting state.

Start Date22 May 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT06054191

/ Not yet recruitingPhase 2IIT

A Phase II, Two Parallel Group Study of Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.

Start Date01 Feb 2024

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Capmatinib Hydrochloride

100 Translational Medicine associated with Capmatinib Hydrochloride

100 Patents (Medical) associated with Capmatinib Hydrochloride

329

Literatures (Medical) associated with Capmatinib Hydrochloride

01 Jan 2026·Cancer Reports

Challenges and Limitations of Sequential MET ‐ TKI Therapy in METex14 ‐ Positive NSCLC With a Focus onNon‐ ILD Toxicities: A Case Report

Article

Author: Uraki, Junji ; Nigi, Akina ; Iwamoto, Keisuke ; Kondou, Shigeto ; Itani, Hidetoshi ; Kumasa, Toshikazu

ABSTRACT:

Background:

Nonsmall cell lung cancer (NSCLC) with mesenchymal‐epithelial transition exon 14 skipping mutation (METex14) represents a distinct molecular subtype with limited therapeutic options. Selective MET tyrosine kinase inhibitors (MET‐TKIs) such as tepotinib, capmatinib, and gumarontinib have improved outcomes, but toxicities frequently limit their use. Previous case reports have described sequential rechallenge with two MET‐TKIs and, in rare cases, with three agents including an investigational drug. To our knowledge, this is the first reported case worldwide of sequential treatment with all three MET‐TKIs currently approved in Japan—tepotinib, capmatinib, and gumarontinib.

Case:

We report a 72‐year‐old man with METex14‐positive NSCLC who underwent surgery and adjuvant chemotherapy, later developing pleural dissemination. Tepotinib was discontinued after 2 months due to Grade 3 interstitial lung disease (ILD). Following chemotherapy and immune checkpoint inhibitors, capmatinib was introduced but stopped within 10 days for fever, mucositis, and possible ILD. Gumarontinib was subsequently initiated, but treatment was interrupted on Day 36 due to Grade 2 hepatotoxicity before resumption at a reduced dose.

Conclusions:

Although all three MET‐TKIs share similar mechanisms of action, they exhibit differing toxicity profiles. In this case, treatment discontinuation was not due to ILD recurrence but rather to distinct non‐ILD adverse events. Furthermore, the toxicities experienced by the patient varied between agents, suggesting that rechallenge may remain a viable strategy depending on individual tolerance. Careful toxicity monitoring and personalized risk assessment are essential when considering sequential MET‐TKI therapy.

01 Jan 2026·JOURNAL OF BIOCHEMICAL AND MOLECULAR TOXICOLOGY

Comparative Toxicovigilance of Capmatinib and Tepotinib in NSCLC: Respiratory Signal Detection and Adverse Event Profiling via FAERS

Article

Author: Liu, Zi ; Shao, Danyan ; Chang, Xing ; Ma, Jingjing ; Bao, Jianan

ABSTRACT:

Capmatinib and tepotinib are selective MET inhibitors for MET exon 14 skipping non‐small cell lung cancer (NSCLC), yet comprehensive real‐world safety profiles, particularly concerning respiratory and rare adverse events (AEs), remain limited. We conducted a disproportionality analysis of the FDA AE Reporting System (FAERS) database, utilizing four algorithms (ROR, PRR, BCPNN, MGPS) to identify AE signals from 1771 cases for capmatinib and 470 for tepotinib, standardized with MedDRA v26.0. Both inhibitors shared signals for systemic AEs, such as peripheral oedema and gastrointestinal disorders. However, their respiratory AE profiles diverged: capmatinib was associated with pleural effusion and pulmonary oedema, whereas tepotinib was linked to infectious complications, including interstitial lung disease and infectious pleural effusion. Importantly, we identified significant novel signals beyond current drug labels: sensory disturbances, and thrombosis for capmatinib; and fluid imbalance‐related events for tepotinib. These distinct AE profiles highlight an infection‐driven pulmonary risk for tepotinib requiring close monitoring, while capmatinib's association with sensory disorders warrants specific patient management considerations. Our findings underscore the need for individualized safety monitoring based on the unique AE profiles of each MET inhibitor.

23 Dec 2025·Science Signaling

Cancer-associated fibroblasts confer ALK inhibitor resistance in EML4-ALK –driven lung cancer by concurrent integrin and MET signaling

Article

Author: Hu, Qianqian ; Rix, Uwe ; Fang, Bin ; Li, Xueli ; Kroeger, Jodi L. ; Wright, Gabriela M. ; Haura, Eric B. ; Marusyk, Andriy ; Remsing Rix, Lily L. ; Welsh, Eric A. ; Doebele, Robert C. ; Desai, Bina ; Miroshnychenko, Daria ; Koomen, John M. ; Chaudhary, Neelkamal

Cancer-associated fibroblasts (CAFs) are associated with tumor progression and drug resistance. Here, we investigated the mechanisms underlying the cross-talk between CAFs and tumor cells in non–small cell lung cancer (NSCLC). In NSCLC cell lines with EML4-ALK fusions, we observed substantial CAF-mediated drug resistance to clinically used inhibitors of the tyrosine kinase ALK. Array-based cytokine profiling of CAF-derived conditioned medium indicated that a major contributor to the phenomenon was the secreted growth factor HGF, and blocking its receptor MET overcame paracrine resistance to ALK inhibition. However, cell-selective labeling of the proteome in cocultures also revealed an equally important contribution by the fibronectin-integrin pathway, specifically integrin β 1 , which was confirmed through pharmacological inhibition and cell-specific silencing or knockout. Concurrent targeting of MET and integrin signaling effectively abrogated ALK inhibitor resistance in EML4-ALK + NSCLC cells cocultured with CAFs. Moreover, the combination of the ALK inhibitor alectinib with the MET inhibitor capmatinib and/or the integrin inhibitor cilengitide was more effective than single-agent treatment in suppressing tumor growth in allografted mice. The findings illustrate a previously unappreciated complex nature of concurrent paracrine and juxtacrine mechanisms of CAF-driven resistance that may inform the development of more effective therapeutic approaches.

News (Medical) associated with Capmatinib Hydrochloride

10 Jan 2026

·www.prnewswire.com

RYBREVANT® (amivantamab-vmjw) longer-term results show promising and durable responses in difficult-to-treat colorectal cancer

Over 70 percent of patients in the first-line subgroup responded to amivantamab plus chemotherapy with most responses lasting beyond 16 months Notable responses were also seen in patients with liver metastases, who often face poorer outcomes with this disease RARITAN, N.J., Jan. 10, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer. Results were presented during a poster session at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium (Abstract #166).1 "These results show the potential of amivantamab combined with chemotherapy to deliver meaningful and durable benefit for people with advanced colorectal cancer, including for those with liver metastases who have historically faced poorer outcomes," said Dr. Filippo Pietrantonio,* M.D., Head of the Gastrointestinal Oncology Unit, IRCCS Foundation, National Cancer Institute, Milan, Italy. "Seeing patients maintain responses for extended periods, some beyond two years, is a powerful sign of progress in a disease where sustained efficacy has been hard to achieve and speaks to the promise of this treatment approach." Colorectal cancer is the third most commonly diagnosed cancer worldwide, and a leading cause of cancer-related death.2 While traditionally seen in older adults, incidence is rising in people under 50.3 More than half of patients will eventually develop metastatic disease, with liver involvement in roughly 70 percent of cases. In this setting, resistance to current first-line therapies often develops early, shortening the time patients can benefit.4 For those with RAS/BRAF wild-type metastatic colorectal cancer with disease progression, second-line options remain limited, with historical response rates of 32 to 36 percent and median progression-free survival (PFS) of 5.4 to 6.4 months using EGFR inhibitors and chemotherapy.5,6,7,8,9,10 Research has shown that MET alterations are a frequent cause of resistance to EGFR-inhibition, highlighting a need for new approaches that target both pathways simultaneously.11 Detailed Study Results Cohorts D and E of the Phase 1b/2 OrigAMI-1 study evaluated intravenous amivantamab as monotherapy or in combination with either FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. Patients were confirmed to be negative for KRAS, NRAS, BRAF and EGFR mutations, and did not have HER2 amplification. They could have received one prior line of systemic therapy in the metastatic setting, and prior treatment with an EGFR inhibitor was not permitted. The primary endpoint was safety, and secondary endpoints included overall response rate (ORR), duration of response (DOR), clinical benefit rate, and PFS. Overall survival was assessed as an exploratory endpoint.1 At a median follow-up of 16 months (range, 1.2-29.5), amivantamab plus FOLFOX (n=20) or FOLFIRI (n=23) achieved a confirmed ORR of 51 percent (95 percent confidence interval [CI], 36-67) across the study, with responses observed early and a median time to first response of 8.3 weeks (range, 7.3-20.3), along with a median DOR of 9.3 months (95 percent CI, 5.8-14.7). Median PFS was 9.2 months (95 percent CI, 5.4-12.9), and median overall survival was not estimable (NE) (95 percent CI, 16.2-NE). In the first-line subgroup, ORR was 73 percent (95 percent CI, 53-86), with median DOR not yet reached at the time of data cutoff (95 percent CI, 7.3-NE). Among 11 patients treated in the first-line subgroup, four were able to proceed to curative intent surgery. In the second-line subgroup (n=32), ORR was 44 percent (95 percent CI, 26-62) and median DOR was 7.4 months (95 percent CI, 5.4-14.5). More than one-third of patients treated in the second-line setting remained on therapy for over one year, and three patients have stayed on amivantamab treatment for more than two years. In patients with liver metastases (n=30), the study showed notable activity, with an ORR of 57 percent (95 percent CI, 37-75) and a median PFS of 11.3 months (95 percent CI, 5.9-16.4).1 The safety profile remained consistent with prior reports of amivantamab plus chemotherapy in colorectal cancer and with the known safety profiles of the individual agents. Treatment-emergent adverse events were primarily related to EGFR and MET inhibition and known chemotherapy-associated effects. Four patients (9 percent) discontinued therapy due to treatment-related adverse events. The most common Grade 3 or higher event was neutropenia, and no new safety signals were observed.1 "Treatment for metastatic colorectal cancer has remained largely unchanged for many years, underscoring the need for new strategies," said Kiran Patel, M.D., Vice President, Global Head, Solid Tumor Clinical Development and Companion Diagnostics, Johnson & Johnson Innovative Medicine. "We are drawing on our scientific leadership in EGFR-driven lung cancer to evaluate the potential of amivantamab, and its dual-targeting of EGFR and MET, in colorectal cancer and other solid tumors driven by these pathways." Pivotal Phase 3 studies, including the global, randomized OrigAMI-2 and OrigAMI-3 studies evaluating subcutaneous amivantamab with FOLFOX and FOLFIRI, are underway to further evaluate the potential of amivantamab-based regimens in both first- and second-line colorectal cancer. About the OrigAMI-1 Study OrigAMI-1 (NCT05379595) is an open-label, Phase 1b/2 study assessing the efficacy and safety of RYBREVANT® plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC. Eligible patients were wild-type (WT) for KRAS, NRAS or BRAF genes based on circulating tumor DNA testing. Additionally, patients were required to have no amplification of the ERBB2/HER2 gene. In the RYBREVANT® and chemotherapy cohorts, patients were either treatment-naïve or had received at least one prior line in the metastatic setting (no EGFR inhibitor treatment). The primary endpoint of the combination cohorts was to characterize the safety and confirm the dose of RYBREVANT® plus mFOLFOX6 or FOLFIRI. Response was assessed by the investigator per RECIST v1.1.12 About Colorectal Cancer Colorectal cancer is the third most common cancer worldwide, accounting for approximately 10 percent of all cancer cases, and is the second leading cause of cancer-related deaths worldwide.2 While it predominantly affects older individuals, recent research suggests that colorectal cancer is now being diagnosed in adults under the age of 50 at record rates.3 Left-sided colorectal cancer, which represents approximately 65 percent of cases, often has distinct characteristics that influence treatment strategies. Around half of colorectal cancer patients have mutations in the RAS genes, with KRAS being the most common mutation. While tumors with normal RAS and BRAF genes generally respond better to EGFR inhibitors, those with RAS and BRAF mutations – particularly on the left side – are associated with poorer outcomes.13 About RYBREVANT® RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.14 RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE® for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)§15 include amivantamab-vmjw (RYBREVANT®) across multiple treatment settings, including its recent inclusion as a NCCN Category 1 preferred option when used with lazertinib (LAZCLUZE®) for first-line treatment of people with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations; see the latest NCCN Guidelines® for NSCLC for complete information. †‡ The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-vmjw (RYBREVANT®)-based regimens, including the combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.†‡ In addition to the Phase 1b/2 OrigAMI-1 study, RYBREVANT® is being studied in multiple clinical trials, including: The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT® in combination with LAZCLUZE® versus osimertinib and versus LAZCLUZE® alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations.16 The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT® (with or without LAZCLUZE®) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations after disease progression on or after osimertinib.17 The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.18 The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE® with subcutaneous (SC) amivantamab compared to RYBREVANT® in patients with EGFR-mutated advanced or metastatic NSCLC.19 The Phase 2 PALOMA-2 (NCT05498428) study assessing SC amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.20 The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of SC amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for SC amivantamab delivery.21 The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.22 The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® in combination with LAZCLUZE® and LAZCLUZE® as a monotherapy in patients with advanced NSCLC with EGFR mutations.23 The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT® and capmatinib combination therapy in locally advanced or metastatic NSCLC.24 The Phase 1/2 swalloWTail (NCT06532032) study assessing RYBREVANT® and docetaxel combination therapy in patients with metastatic NSCLC.25 The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT® and cetrelimab combination therapy in locally advanced or metastatic NSCLC.26 The Phase 2 SKIPPirr (NCT05663866) study exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT® in combination with LAZCLUZE® in relapsed or refractory EGFR-mutated advanced or metastatic NSCLC.27 The Phase 2 COPERNICUS (NCT06667076) study combining developments in treatment administration and prophylactic supportive care in representative US patients with common EGFR-mutated NSCLC treated with SC amivantamab in combination with LAZCLUZE® or chemotherapy.28 The Phase 2 COCOON (NCT06120140) study assessing the effectiveness of a proactive dermatologic management regimen given with first-line RYBREVANT® and LAZCLUZE® in patients with EGFR-mutated advanced NSCLC.29 The Phase 3 OrigAMI-2 (NCT06662786) study assessing subcutaneous amivantamab and mFOLFOX6 or FOLFIRI in patients with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer.30 The Phase 3 OrigAMI-3 (NCT06750094) study assessing subcutaneous amivantamab and FOLFIRI in patients with KRAS/NRAS and BRAF wild-type recurrent, unresectable or metastatic colorectal cancer after disease progression on chemotherapy.31 The Phase 1b/2 OrigAMI-4 (NCT06385080) study assessing RYBREVANT® monotherapy and in addition to standard-of-care therapeutic agents in patients with recurrent/metastatic head and neck squamous cell carcinoma.32 The Phase 3 OrigAMI-5 (NCT07276399) study assessing SC amivantamab with pembrolizumab and carboplatin in patients with recurrent/metastatic head and neck squamous cell carcinoma.33 The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc. INDICATIONS RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT® (amivantamab-vmjw) are indicated: in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy. IMPORTANT SAFETY INFORMATION14,34 CONTRAINDICATIONS RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours. RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1). Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity. Infusion-Related Reactions with RYBREVANT® RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour. RYBREVANT® with LAZCLUZE® In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients. RYBREVANT® with Carboplatin and Pemetrexed Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients. RYBREVANT® as a Single Agent In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients. Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®. Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis. RYBREVANT® with LAZCLUZE® In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis. RYBREVANT® with Carboplatin and Pemetrexed Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis. RYBREVANT® as a Single Agent In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE® RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment. RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390). RYBREVANT® with LAZCLUZE® In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification. Dermatologic Adverse Reactions RYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin. RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients. RYBREVANT® with LAZCLUZE® In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®. RYBREVANT® with Carboplatin and Pemetrexed Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed. RYBREVANT® as a Single Agent In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE®, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen. If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severity. Ocular Toxicity RYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis. RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3. RYBREVANT® with LAZCLUZE® In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients. RYBREVANT® with Carboplatin and Pemetrexed Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2. RYBREVANT® as a Single Agent In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2. Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® and continue LAZCLUZE® based on severity. Embryo-Fetal Toxicity Based on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®. ADVERSE REACTIONS RYBREVANT FASPRO™ with LAZCLUZE® In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%). Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each). RYBREVANT® with LAZCLUZE® In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%). Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). RYBREVANT® with Carboplatin and Pemetrexed In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%). In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each). In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%). In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified. RYBREVANT® as a Single Agent In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%). Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death. LAZCLUZE® DRUG INTERACTIONS Avoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4. Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate. Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®. cp-491009v1 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT® (amivantamab-vmjw). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Dr. Filippo Pietrantonio, M.D. has served as a consultant to Johnson & Johnson; he has not been paid for any media work. §The NCCN Content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. †See the NCCN Guidelines for detailed recommendations, including other treatment options. ‡The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories. 1 Chen E, et al. Amivantamab plus FOLFOX or FOLFIRI in RAS/BRAF wild-type metastatic colorectal cancer: Long-term follow-up from the phase 1b/2 OrigAMI-1 study. Presented at: 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium; January 10, 2026; San Franscico, California. 2 Cervantes A, Adams R, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10-32. doi:10.1016/j.annonc.2022.10.003 3 Virostko J, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;125:3828-3835. 4 Patel RK, Rahman S, Schwantes IR, et al. Updated management of colorectal cancer liver metastases: scientific advances driving modern therapeutic innovations. Cell Mol Gastroenterol Hepatol. 2023;16(6):881-894. doi:10.1016/j.jcmgh.2023.08.012 5 Grothey A, Lenz HJ. Exploring new treatments for advanced colorectal cancer: current standards and future directions. Cancer Treat Rev. 2020;86:102017. doi:10.1016/j.ctrv.2020.102017 6 Kumar A, Gautam V, et al. Current and emerging therapeutic approaches for colorectal cancer: A comprehensive review. World J Gastrointest Surg. 2023;15(4):495-519. doi:10.4240/wjgs.v15.i4.495 7 Iwamoto S, Hazama S, Kato T, et al. Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study. Anticancer Res. 2014;34(4):1967-1973. 8 Peeters M, Price TJ, Cervantes A, et al. Final results from a randomized phase 3 study of FOLFIRI {+/-} panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol. 2014;25(1):107-116. doi:10.1093/annonc/mdt523 9 Santini A, Lenz HJ, Eng C, et al. Extended RAS analysis of the phase III EPIC trial: irinotecan plus cetuximab versus irinotecan as second-line treatment for patients with metastatic colorectal cancer. Oncologist. 2021;26(2):e261-e269. doi:10.1002/onco.13591 10 Peeters M, Oliner KS, Price TJ, et al. Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer. Clin Cancer Res. 2015;21(24):5469-5479. doi:10.1158/1078-0432.CCR-15-0526 11 Feldt SL, Bestvina CM. The Role of MET in Resistance to EGFR Inhibition in NSCLC: A Review of Mechanisms and Treatment Implications. Cancers (Basel). 2023;15(11):2998. doi:10.3390/cancers15112998 12 ClinicalTrials.gov. A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1). . Accessed January 2026. 13 Lieu CH, et al. Integrating biomarkers and targeted therapy into colorectal cancer management. Am Soc Clin Oncol Educ Book. 2019;39:207-215. doi:10.1200/EDBK_240839 14 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 15 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed January 2026. 16 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). . Accessed January 2026. 17 ClinicalTrials.gov. A Study of Amivantamab and LAZCLUZE® in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2). Available at: . Accessed January 2026. 18 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON). Available at: . Accessed January 2026. 19 ClinicalTrials.gov. A Study of LAZCLUZE® With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA 3). . Accessed January 2026. 20 ClinicalTrials.gov. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2). . Accessed January 2026. 21 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA). Available at: . Accessed January 2026. 22 ClinicalTrials.gov. A Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS). . Accessed January 2026. 23 ClinicalTrials.gov. A Study of LAZCLUZE® as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). . Accessed January 2026. 24 ClinicalTrials.gov. A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (METalmark). . Accessed January 2026. 25 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer (swalloWTail). . Accessed January 2026. 26 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (PolyDamas). . Accessed January 2026. 27 ClinicalTrials.gov. Premedication to Reduce Amivantamab Associated Infusion Related Reactions (SKIPPirr). . Accessed January 2026. 28 ClinicalTrials.gov. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS). . Accessed January 2026. 29 ClinicalTrials.gov. Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (COCOON). . Accessed January 2026. 30 ClinicalTrials.gov. A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/ NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2). . Accessed January 2026. 31 ClinicalTrials.gov. A Study of Amivantamab and FOLFIRI Versus Cetuximab/ Bevacizumab and FOLFIRI in Participants With KRAS/ NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy (OrigAMI-3). . Accessed January 2026. 32 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). . Accessed January 2026. 33 ClinicalTrials.gov. A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-5). . Accessed January 2026. 34 LAZCLUZE® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. SOURCE Johnson & Johnson 21% more press release views with Request a Demo

Clinical ResultPhase 2ASCOPhase 3Drug Approval

06 Jan 2026

·pmlive.com

Novartis agrees to lower drug prices in deal with US government

Novartis has announced an agreement with the US government to lower the prices of its medicines in the US and support continued investment in US R&D and manufacturing. Novartis has agreed to take a variety of actions with the goal of meeting the US government’s current drug pricing priorities. These include: Launching future medicines with comparable prices across high-income countries Building direct-to-patient platforms for Mayzent (siponimod), Rydapt (midostaurin) and Tabrecta (capmatinib) Applying to participate in the GENEROUS (GENErating cost Reductions fOr US Medicaid) programme, designed to further improve access to Medicaid medicines Supporting efforts to address global imbalances in pharmaceutical innovation investment. In 2025, Novartis announced a commitment to invest $23bn to expand its manufacturing and R&D presence in the US over the next five years. Since the announcement in April 2025, Novartis has taken a number of key steps towards this goal. It announced a new $1.1bn biomedical research hub in San Diego, California, as well as a new flagship manufacturing hub in North Carolina. This hub will include three new facilities and enable end-to-end manufacturing capabilities. Additionally, Novartis opened a new radioligand therapy (RLT) manufacturing facility in Carlsbad, California, and advanced plans to build new RLT manufacturing facilities in Florida and Texas. The agreement means that US pharmaceutical tariffs on the company will be delayed for three years. Vas Narasimhan, CEO of Novartis, said: “This agreement continues our long-term partnership with the US government to advance the development and manufacturing of breakthrough treatments for patients in the US. “We are committed to working with governments worldwide to ensure innovation is appropriately valued and that our medicines reach the patients who need them most.”

22 Dec 2025

·www.biospace.com

Novartis and US government reach agreement on lowering drug prices in the US

Novartis agrees to take actions aimed at meeting US Administration priorities for drug pricing Additional Novartis medicines will be made available through direct-to-patient platforms in 2026 Company remains committed to investing in markets that value innovation and implement policies that support broad and fast access to medicines Basel, December 19, 2025 – Novartis, a leading global innovative medicines company, today announced it has reached an agreement with the US government that aims to lower the price of innovative medicines in the US and support continued US investment in manufacturing, and research and development. Novartis has voluntarily agreed to take actions aimed at meeting the US Administration’s drug pricing priorities, including: Launching future medicines with comparable prices across high-income countries Building direct-to-patient platforms for Mayzent ® (siponimod), Rydapt ® (midostaurin) and Tabrecta ® (capmatinib). These new platforms will be accessible through TrumpRx Applying to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model aimed at further improving access to medicines in the US Medicaid program Supporting efforts to address the global imbalance in investment in pharmaceutical innovation “This agreement continues our long-term partnership with the US government to advance the development and manufacturing of breakthrough treatments for patients in the United States,” said Vas Narasimhan, CEO of Novartis. “We are committed to working with governments worldwide to ensure innovation is appropriately valued and that our medicines reach the patients who need them most.” Earlier this year, Novartis committed to investing $23 billion in expanding its US R&D and manufacturing infrastructure over 5 years. Since announcing this investment in April, the company: Announced a new $1.1 billion biomedical research hub in San Diego, CA Broke ground on a new flagship manufacturing hub in North Carolina, including three new facilities, in the Raleigh/Durham area. The hub will enable end-to-end manufacturing capabilities to produce medicines across the company’s technology platforms Opened a new radioligand therapy (RLT) manufacturing facility in Carlsbad, CA, enabling coast-to-coast manufacturing of RLTs Advanced plans to build new RLT manufacturing facilities in Florida and Texas In recognition of this investment, Novartis expects to receive three years of tariff relief. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release; or regarding potential future revenues from such products; or regarding our agreement with the US government aiming to lower the price of innovative medicines in the US; or regarding discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new US R&D capabilities and manufacturing. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits from the agreements and investments described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

100 Deals associated with Capmatinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Capmatinib Hydrochloride	L01XE	DB11791

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	United States	Novartis Pharmaceuticals Corp.	06 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	NDA/BLA	China	Novartis Pharma Schweiz AG	25 Feb 2023
Non-Small Cell Lung Cancer	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	25 Feb 2023
Glioma	Phase 3	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	19 Nov 2024
Hematologic Neoplasms	Phase 3	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	19 Nov 2024
Neuroblastoma	Phase 3	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	19 Nov 2024
Soft Tissue Sarcoma	Phase 3	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	19 Nov 2024
Stomach Cancer	Phase 3	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	19 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 3	United States	Novartis Pharma Produktions GmbH	22 Sep 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 3	United States	China Novartis Institutes for BioMedical Research Co., Ltd.	22 Sep 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 3	United States	Novartis Pharma AG	22 Sep 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line MET Exon 14 Skipping+	17	Capmatinib	ifvehubpir(yvhvjmqwzp) = sallrwnkrj ghvyqjkiov (ywwotsfmvz ) View more	Positive	30 May 2025
				Tepotinib	ifvehubpir(yvhvjmqwzp) = ekwvbtqpjd ghvyqjkiov (ywwotsfmvz ) View more
NCT05243641 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	10	Neratinib+Capmatinib (Phase Ib)	sbsyuqsdno = ndrszrgwga dmotpnfvtg (xxsomsqbtr, prnpzzhzur - jczinbfapb)	-	15 May 2025
				neratinib+capmatinib (Phase II)	prmfsrdsfq(uhazbpydcm) = dcwyrmkjra rsklslxdia (mdrvlmzeff, kjrmrrbkdu - tjcjwnjsmt) View more
NCT04926831 (Geometry-N, CTgov)	Phase 2	Non-small cell lung cancer stage IIIA \| Non-Small Cell Lung Cancer	4	capmatinib	wxcbauhdyy = ddmckegpdc ubuhmfphtc (jdaskvtcer, hqyqxerwra - upidplwmes) View more	-	26 Mar 2025
NCT04427072 (GeoMETry-III, CTgov)	Phase 3	Non-Small Cell Lung Cancer	22	Capmatinib (Capmatinib)	gexcyzlsru(lktkzkqnyt) = niplypjxlj xdhdhythff (zlkckqzxpx, vqorutinrg - isicsrefek) View more	-	30 Jan 2025
				Docetaxel (Docetaxel)	gexcyzlsru(lktkzkqnyt) = rfgqbegjyi xdhdhythff (zlkckqzxpx, hvkwoswolh - scucxmahjr) View more
NCT02386826 (Pubmed)	Phase 1	High grade glioma	64	卡马替尼+贝伐珠单抗	zxcocmtufv(jpiryevktn) = ekdtapnfns zbxqvrmsdm (cqtstzsyzm )	Positive	11 Dec 2024
NCT02414139 (GEOMETRY mono-1, Pubmed \| Lancet Oncol) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	373	Capmatinib 400 mg orally twice daily	sohuytadku(taqhmbfxqe) = mtckdddala npgomggaeh (lswqsxcypr ) View more	Positive	01 Oct 2024
				Capmatinib (treatment-naive)	sohuytadku(taqhmbfxqe) = ppsppzyifo npgomggaeh (lswqsxcypr, 55.0 - 79.7)
NCT02414139 (GEOMETRY mono-1, WCLC2024) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line MET Exon 14 Skipping	-	Capmatinib	hinolfuppr(wvmxyoqrdw): P-Value = 0.532 View more	Positive	07 Sep 2024
				Savolitinib
NCT02335944 (Pubmed) Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation ... View more	144	Capmatinib Nazartinib plus Nazartinib 100 mg qd	cvpyrjrdbz(kzdteajaon) = msetazxgng ognmutgepc (nufogvxilj )	Positive	01 Sep 2024
				Capmatinib+Nazartinib (fasted; EGFR-TKI naïve; 0-2 prior lines; de novo T790M+; any MET)	cvpyrjrdbz(kzdteajaon) = fqjnpklitu ognmutgepc (nufogvxilj )
NCT02323126 (Pubmed \| Lung Cancer) Manual	Phase 2	EGFR positive non-small cell lung cancer MET Exon 14 Skipping \| MET Expression	46	Capmatinib 400 mgNivolumab	fzffndlhqt(xegdqngblr) = sceendhdvp wslrrdzyuz (lndyalcxcs, 48.5 - 85.7) Met View more	Positive	01 Jun 2024
				Capmatinib3 mg/kgNivolumab	fzffndlhqt(xegdqngblr) = mqdjqcoudq wslrrdzyuz (lndyalcxcs, 35.6 - 66.4) Met View more
ESMO_ELCC2024	Not Applicable	Non-Small Cell Lung Cancer MET exon 14 skipping mutation	146	Capmatinib	wehfxnrmro(cllxatrogb) = mnarkwzepb tlbkhjdgas (rpsvznnycd ) View more	Positive	22 Mar 2024
				Tepotinib	wehfxnrmro(cllxatrogb) = fksrgzmlaj tlbkhjdgas (rpsvznnycd ) View more

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