RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC34H45BrN4O4

InChIKeyUQRICAQPWZSJNF-UHFFFAOYSA-N

CAS Registry1467052-75-0

Clinical Trials associated with Tazemetostat Hydrobromide

NCT06068881

/ Not yet recruitingPhase 2

A Phase 2, Open-label, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Oral Tazemetostat for the Treatment of Adult Participants Age 18 and Over With Relapsed/Refractory Follicular Lymphoma Lacking the EZH2 Gain-of-Function (GOF) Mutation

The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an "EZH2 gain-of-function" genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. 'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2" mutation who have no satisfactory alternative treatment options.
This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2 gain-of-function" genetic mutation and who previously received therapies commonly used in the U.S. in your body.
'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2 gain-of-function" mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2" genetic mutation and who previously received therapies commonly used in the U.S.
In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests).
The study consists of 4 periods:
* Screening period may take up to 4 weeks and require at least 1 visit.
* Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 12 months, followed by 1 visit every 3 months (except for women of childbearing potential [WOCBP], who will continue to have a pregnancy testing every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first.
* Safety follow-up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call.
* Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first, and will require a visit every 3 months.
Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress.
Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.

Start Date02 Sep 2025

Sponsor / Collaborator

Epizyme, Inc.

[+1]

NCT06575686

/ RecruitingPhase 2IIT

A Phase 2 Study of Epcoritamab Plus Tazemetostat for Treatment of Relapsed/Refractory Follicular Lymphoma

This phase II trial tests the safety, side effects and effectiveness of epcoritamab and tazemetostat in treating patients with grade I-IIIa follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens on the surface of cancer cells that may help the body's immune system attack the cancer and may interfere with the ability of the cancer cells to grow and spread. Tazemetostat, a EZH2 inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving epcoritamab and tazemetostat may be safe, tolerable and/or effective in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma.

Start Date20 Apr 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06824701

/ Not yet recruitingPhase 1IIT

A Phase 1b Study of Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphomas

The purpose of this clinical trial is to learn if the study drug Tazemetostat combined with Zanubrutinib and anti-CD20 monoclonal antibody is safe and effective in treating patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.

Start Date01 Apr 2025

Sponsor / Collaborator

University of Utah

[+1]

100 Clinical Results associated with Tazemetostat Hydrobromide

100 Translational Medicine associated with Tazemetostat Hydrobromide

100 Patents (Medical) associated with Tazemetostat Hydrobromide

452

Literatures (Medical) associated with Tazemetostat Hydrobromide

01 Dec 2025·FUNCTIONAL & INTEGRATIVE GENOMICS

Polycomb repressive complex 2 (PRC2) pathway’s role in cancer cell plasticity and drug resistance

Review

Author: Tabari, Mohammad Amin Khazeei ; Khan, Haroon ; Javan, Alireza ; Larsen, Danaé S ; Rezaee, Aryan ; Heidari, Mohammad Mahdi ; Sanaye, Pantea Majma ; Hadipour, Mahboube ; Goleij, Pouya ; Daglia, Maria

Polycomb Repressive Complex 2 (PRC2) is a central regulator of gene expression via the trimethylation of histone H3 on lysine 27. This epigenetic modification plays a crucial role in maintaining cell identity and controlling differentiation, while its dysregulation is closely linked to cancer progression. PRC2 silences tumor suppressor genes, promoting cell proliferation, metastasis, epithelial-mesenchymal transition, and cancer stem cell plasticity. Enhancement of zeste homolog 2 (EZH2) overexpression or gain-of-function mutations have been observed in several cancers, including lymphoma, breast, and prostate cancers, driving aggressive tumor behavior and drug resistance. In addition to EZH2, other PRC2 components, such as embryonic ectoderm development (EED) and suppressor of zeste 12, are essential for complex stability and function. EED, in particular, enhances EZH2 activity and has emerged as a therapeutic target. Inhibitors like MAK683 and EED226 disrupt EED's ability to maintain PRC2 activity, thereby reducing H3K27me3 levels and reactivating tumor suppressor genes. Valemetostat, a dual inhibitor of both EZH2 and EED, has shown promising results in aggressive cancers like diffuse large B-cell lymphoma and small-cell lung cancer, underlining the therapeutic potential of targeting multiple PRC2 components. PRC2's role extends beyond gene repression, as it contributes to metabolic reprogramming in tumors, regulating glycolysis and lipid synthesis to fuel cancer growth. Furthermore, PRC2 is implicated in chemoresistance, particularly by modulating DNA damage response and immune evasion. Tazemetostat, a selective EZH2 inhibitor, has demonstrated significant clinical efficacy in EZH2-mutant cancers, such as non-Hodgkin lymphomas and epithelioid sarcoma. However, the compensatory function of enhancer of zeste homolog 1 (EZH1) in some cancers requires dual inhibition strategies, as seen with agents like UNC1999 and Tulmimetostat, which target both EZH1 and EZH2. Given PRC2's multifaceted role in cancer biology, its inhibition represents a promising avenue for therapeutic intervention. The continued development of PRC2 inhibitors and exploration of their use in combination with standard chemotherapy or immunotherapy has great potential for improving patient outcomes in cancers driven by PRC2 dysregulation.

01 Apr 2025·EClinicalMedicine

Efficacy of tazemetostat in combination with R-CHOP in elderly patients newly diagnosed with diffuse large B cell lymphoma: results of the EpiRCHOP phase II study of the LYSA

Article

Author: Guidez, Stéphanie ; Crochet, Gilles ; Bonnet, Christophe ; Gastinne, Thomas ; Houot, Roch ; Ysebaert, Loic ; Morschhauser, Franck ; Molina, Thierry Jo ; Bachy, Emmanuel ; Jardin, Fabrice ; Thieblemont, Catherine ; Sarkozy, Clémentine ; Veresezan, Liana ; Herbaux, Charles ; Ruminy, Philippe ; Dubois, Sydney ; Haioun, Corinne ; Bohers, Elodie ; Portugues, Cédric ; Pica, Gian Matteo ; Ribrag, Vincent ; Choquet, Sylvain

Background:

In the phase I Epi-RCHOP study (NCT02889523), we reported that R-CHOP-tazemetostat was well tolerated with the recommended phase II dose, consistent with monotherapy.

Methods:

Phase II included newly diagnosed diffuse large B cell lymphoma patients aged 60-80 years who received six cycles of rituximab-CHOP (R-CHOP) with continuous tazemetostat (800 mg BID), plus two cycles of tazemetostat and rituximab (cycles 7 and 8), from July 31, 2020 to July 18, 2022. Primary endpoint was positron emission tomography complete metabolic response (CMR). Sample size was calculated with H0 of 70% and H1 assumption of 80%.

Findings:

The trial enrolled 122 patients: median age 70 (60-80), 90.2% with stage III-IV, and 73.8% with International Prognostic Index 3-5. Overall, 100 patients (82%) received eight cycles, while 22 had premature treatment discontinuation (PTD), including 12 during the first two cycles. Reasons for PTD were consent withdrawal (N = 10), adverse events (N = 6), death (N = 2), protocol deviation (N = 2), progressive disease (N = 1), and physician decision (N = 1). The median percentage of relative dose intensity of tazemetostat and R-CHOP exceeded 90%, but required a protocol amendment and reduction in vincristine dosage at 1 mg full dose. At the end of treatment or PTD, 92/122 patients (75.4%) achieved CMR, eight (6.6%) partial metabolic response, five (4.1%) progressive disease, two (1.6%) died (septic shock), and 15 (12.3%) were not evaluated. Sensitivity analysis, excluding ten non-evaluated patients who withdrew consent, showed CMR in 82.1%. After a median follow-up of 18.5 months (IQR: 15.4-21), estimated progression-free and overall survival at 18 months were 77.7% (95% CI: 67.5-85.1%) and 88.8% (95% CI: 79.9-93.9%), respectively.

Interpretation:

R-CHOP plus tazemetostat is feasible with a promising CMR in elderly DLBCL patients. Complementary biomarker studies are needed for a more personalized approach.

Funding:

This study was sponsored under a grant from Ipsen.

01 Mar 2025·CANCER CELL

EZH1/EZH2 inhibition enhances adoptive T cell immunotherapy against multiple cancer models

Article

Author: Schuster, Stephen J ; Fardella, Eugenio ; Carturan, Alberto ; Zhang, Yunlin ; Isshiki, Yusuke ; Porazzi, Patrizia ; Paruzzo, Luca ; Chen, Linhui ; Delman, Devora ; Ruella, Marco ; Patel, Ruchi P ; Béguelin, Wendy ; Beatty, Gregory L ; Pajarillo, Raymone ; Guruprasad, Puneeth ; Blanchard, Tatiana ; Ghilardi, Guido ; Shestova, Olga ; Yang, Ziqi ; Markowitz, Kelly ; Lemoine, Jean ; Nason, Siena ; Linette, Gerald P ; Cohen, Ivan J ; Melnick, Ari M ; Padmanabhan, Anushka Anant ; Angelos, Mathew G ; Tan, Melody ; Carreno, Beatriz M ; Ugwuanyi, Ositadimma

Tumor resistance to chimeric antigen receptor T cell (CAR-T) and, in general, to adoptive cell immunotherapies (ACTs) is a major challenge in the clinic. We hypothesized that inhibiting the tumor drivers' methyltransferases EZH2 and EZH1 could enhance ACT by rewiring cancer cells to a more immunogenic state. In human B cell lymphoma, EZH2 inhibition (tazemetostat) improved the efficacy of anti-CD19 CAR-T by enhancing activation, expansion, and tumor infiltration. Mechanistically, tazemetostat-treated tumors showed upregulation of genes related to adhesion, B cell activation, and inflammatory responses, and increased avidity to CAR-T. Furthermore, tazemetostat improved CAR- and TCR-engineered T cell efficacy in multiple liquid (myeloma and acute myeloid leukemia) and solid (sarcoma, ovarian, and prostate) cancers. Lastly, combined EZH1/EZH2 inhibition (valemetostat) further boosted CAR-T efficacy and expansion in multiple cancers. This study shows that EZH1/2 inhibition reprograms tumors to a more immunogenic state and potentiates ACT in preclinical models of both liquid and solid cancers.

News (Medical) associated with Tazemetostat Hydrobromide

25 Mar 2025

·www.globenewswire.com

HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma

— First and only EZH2 inhibitor approved by the NMPA — — HUTCHMED’s fourth product, and its first approval in hematological malignancies — March 21, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior systemic therapies. This approval follows the priority review status by the National Medical Products Administration (“NMPA”) and marks the first nationwide regulatory approval for TAZVERIK® in China. The conditional approval by the NMPA was supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme, Inc. (“Epizyme”), an Ipsen company, outside China. The primary objective of the bridging study is to evaluate the objective response rate (“ORR”) of TAZVERIK® for the treatment of patients with R/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), and overall survival (OS) of TAZVERIK® for the treatment of R/R FL patients, as well as to evaluate the safety and pharmacokinetics. Additional details can be found at clinicaltrials.gov, using identifier NCT05467943. “This approval represents a significant advancement in the management of this challenging disease. The majority of FL patients experience multiple relapses over their lifetime, posing substantial treatment difficulties and often leading to poor outcomes,” said Dr Junning Cao of Fudan University Cancer Center and the lead principal investigator of the bridging study. “TAZVERIK® has demonstrated promising efficacy in patients harboring EZH2 mutation in clinical trials. We are eager to provide this transformational epigenetic therapy to patients in China who have long sought new effective treatment options.” “We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering,” said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “It also marks our first approval in hematological malignancies, unveiling a new chapter for HUTCHMED as we extend our footprint into this disease area. As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases.” TAZVERIK® is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. It is approved by the US Food and Drug Administration (“FDA”) for the treatment of certain patients with R/R FL and certain patients with advanced epithelioid sarcoma (“ES”) under the FDA accelerated approval program. It is also approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for certain patients with R/R FL. In 2021, HUTCHMED and Epizyme entered a strategic partnership. HUTCHMED is responsible for the research, development, manufacturing and commercialization of TAZVERIK® in China Mainland, Hong Kong, Macau and Taiwan. Epizyme will be the Marketing Authorization Holder of TAZVERIK® in China. TAZVERIK® was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA. TAZVERIK® was approved in Macau in March 2023 and in Hong Kong in May 2024. The ongoing SYMPHONY-1 study will serve as the confirmatory trial to validate the clinical benefits of TAZVERIK®. SYMPHONY-1 is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study, which is designed to evaluate the safety and efficacy of TAZVERIK® in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (NCT04224493). Epizyme is the sponsor of SYMPHONY-1 and HUTCHMED is leading the study in China. FL is the second most common subtype of non-Hodgkin’s lymphoma (“NHL”), making up 20-30% of all NHL. In 2022, there were an estimated 81,000 and 78,000 new cases of NHL in China and the US, respectively.1,2,3 Tazemetostat is a methyltransferase inhibitor indicated in the United States for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection. Adult patients with R/R FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. Adult patients with R/R FL who have no satisfactory alternative treatment options. These indications are approved under accelerated approval by the US FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The most common (≥20%) adverse reactions in patients with ES are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with FL are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain. TAZVERIK® is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable). TAZVERIK® is commercialized by Epizyme in the US and by Eisai in Japan. TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company. HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. 1 NCCN Guidelines for Patients: Follicular Lymphoma. https://www.nccn.org/patients/guidelines/content/PDF/nhl-follicular-patient.pdf. Accessed February 17, 2025. 2 SEER Cancer Stat Facts: Follicular Lymphoma. National Cancer Institute. https://seer.cancer.gov/statfacts/html/follicular.html. Accessed February 17, 2025 3 The Global Cancer Observatory (GLOBOCAN), Cancer Today | IARC. https://gco-iarc-who-int.libproxy1.nus.edu.sg/today/en/dataviz/bars?cancers=34. Accessed February 17, 2025. The content above comes from the network. if any infringement, please contact us to modify.

$HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma$

Drug ApprovalPriority ReviewImmunotherapyClinical Result

21 Mar 2025

·www.pharmaceutical-technology.com

China conditionally approves Hutchmed’s Tazverik for follicular lymphoma

The bridging study’s main objective is to assess the objective response rate of the therapy in subjects with R/R FL with EZH2 mutations. Credit: Chay_Tee/Shutterstock. China’s National Medical Products Administration (NMPA) has granted conditional approval for Hutchmed’s Tazverik (tazemetostat) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) with enhancer of zeste homolog 2 (EZH2) mutation. The decision is intended for individuals who have undergone a minimum of two previous systemic therapies. This is the first regulatory approval for the therapy in China and comes after it gained NMPA’s priority review status. Hutchmed chief medical officer and research and development (R&D) head Dr Michael Shi stated: “We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering. “As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases.” The conditional approval was based on the outcomes from the multicentre, open-label, Phase II bridging study in the country, alongside clinical trials conducted outside the country by Ipsen’s Epizyme, the developer of the therapy. The bridging study’s main objective is to assess the objective response rate (ORR) of the therapy in treating subjects with R/R FL with EZH2 mutations. Secondary objectives are progression-free survival, overall survival and duration of response, along with assessment of the therapy’s pharmacokinetics and safety. Hutchmed and Epizyme entered a strategic collaboration in 2021, with the former taking on the responsibilities for the therapy’s research, development, manufacturing and commercialisation in mainland China, Macau, Taiwan and Hong Kong, while the latter holds marketing authorisation in the country. In January 2025, the NMPA granted acceptance and priority review for the new drug application for Hutchmed’s Orpathys and Tagrisso combo, targeting individuals with locally advanced or metastatic non-small cell lung cancer.

Phase 2Drug ApprovalPriority Review

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

100 Deals associated with Tazemetostat Hydrobromide

External Link

KEGG	Wiki	ATC	Drug Bank
D11485	Tazemetostat Hydrobromide	L01	DB12887

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Follicular Lymphoma	United States	Epizyme, Inc.	18 Jun 2020
Sarcoma	United States	Epizyme, Inc.	23 Jan 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Refractory Follicular Lymphoma	Phase 3	United States	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	China	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Australia	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Belgium	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Canada	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	France	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Germany	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Hungary	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Italy	Epizyme, Inc.	11 Jun 2020
Refractory Follicular Lymphoma	Phase 3	Poland	Epizyme, Inc.	11 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02601950 (CTgov)	Phase 2	Typical Teratoid Rhabdoid Tumor \| Chordoma \| Renal Medullary Carcinoma ... View more	267	tazemetostat (Rhabdoid Tumors: Cohort 1)	odlaykinny = rmeepkpbjt toepvjvpco (eqfdapdeld, nqjqqudisd - ejcfxctywh) View more	-	11 Mar 2025
				tazemetostat (Other INI1-negative: Cohort 3)	odlaykinny = zfwealwvnh toepvjvpco (eqfdapdeld, jeldlafbfz - zbwbftswab) View more
NCT03348631 (CTgov)	Phase 2	Recurrent Ovarian Clear Cell Adenocarcinoma \| Endometrial Endometrioid Adenocarcinoma \| Recurrent ovarian cancer ... View more	62	Tazemetostat (Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients)	msknajhoib = svnujfolxu mwrjcrfhko (qvjdrciysd, atljehrsvd - ncegkscluu) View more	-	06 Mar 2025
				Tazemetostat (Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients)	msknajhoib = qzymvswtoy mwrjcrfhko (qvjdrciysd, ynwovofdgm - jqhllnboyi) View more
ASH2024	Not Applicable	Follicular Lymphoma	-	Tazemetostat 800mg BID	siwuxjoiko(jesflomnkd) = leukopenia (n=2), neutropenia (n=1), anemia (n=1), atrial fibrillation (n=1), bone pain (n=1), infection (n=2), and infusion related reaction (n=1) bpzemvsrjo (kwiyjghfkm ) View more	-	09 Dec 2024
NCT04179864 (EZH-1101, ESMO2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	81	TAZ 1200 mg BID plus ENZ 160 mg QD	hbfmgzwoef(aqfpcstmwb) = rwjgnhnytk pfwsvgcozw (twvqvohvgw, 8.5 - NE) View more	Negative	15 Sep 2024
				ENZ 160 mg QD	hbfmgzwoef(aqfpcstmwb) = medikfuijb pfwsvgcozw (twvqvohvgw, 6.6 - NE) View more
NCT04537715 (CTgov)	Phase 1	Renal Medullary Carcinoma \| Follicular Lymphoma \| Rhabdoid Tumor ... View more	42	Tazemetostat (Part 1: Tazemetostat)	wmfjrwrddk(erjxjhsctn) = ytywejpgzl pwmyopeuyb (vujvufhmep, 55.3) View more	-	26 Aug 2024
				Tazemetostat (Part 2: Tazemetostat)	vjsiokxgpk(eqqpcivnvq) = pttmlwaipv ssokympfgz (ngdbwxrqhd, 83.2) View more
NCT03854474 (ETCTN 10183, ASCO2024)	Phase 1/2	Advanced Urothelial Carcinoma COMPASS-related proteins KMT2D \| KMT2C \| KDM6A ... View more	-	Tazemetostat 800 mg BID + Pembrolizumab 200 mg	suyvxvhgng(kooeyjowya) = knwiuqndno oxecerhgmr (hdnqctiudq ) View more	-	24 May 2024
				Pembrolizumab 200 mg	suyvxvhgng(kooeyjowya) = zokoimzeee oxecerhgmr (hdnqctiudq ) View more
NCT05372354 (CA057-003, EHA2024) Manual	Phase 1/2	Multiple Myeloma PRC2 Loss of Function Mutation \| EZH2 Overexpression	10	MEZI+TAZ+DEX 0.3mg	ncluvrqqgy(nujyfifezg) = rxcwajsovz lquurfdzhp (vqnclmywiz ) View more	Positive	14 May 2024
NCT05713110 (EHA2024)	Phase 2	Lymphoma	21	Tazemetostat 800mg BID	yliqofocic(ozznqupvlo) = 4 pts, 19.0% gmloqtwzzn (gguivudopt ) View more	Positive	14 May 2024
				Amdizalisib 30mg QD
NCT04224493 (SYMPHONY-1, ASH2023)	Phase 3	Refractory Follicular Lymphoma	815	Tazemetostat plus Lenalidomide and Rituximab	ozqenivnhi(zlfvnwdzmk) = cfyevponek tkixupbvsj (ebqznygvbm )	Positive	11 Dec 2023
				Lenalidomide and Rituximab	ozqenivnhi(zlfvnwdzmk) = pmrryhqvba tkixupbvsj (ebqznygvbm )
ASH2023	Phase 2	Follicular Lymphoma	62	Tazemetostat 800mg BID + R-CHOP	ghiijytctm(oilhoamdft) = sdpzvyxaxk kgmdnkiinr (kdgxnyagin ) View more	-	09 Dec 2023

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