Skip to main content

tazemetostat

Generic: tazemetostat·Brand: Tazverik

tazemetostat: developed by 1 company · 16 clinical trials tracked · 1 FDA decision.

tazemetostat evidence translation

What we can confirm

1 FDA record · 16 tracked trials

What it means

Source-backed records connect tazemetostat to EPZM; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could tazemetostat → EPZM affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 1 study sponsors
Development Pipeline (1)
Clinical Trials (16)showing 10 most recent

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

NCT06068881·Phase 2·EPZM
Withdrawn

Primary endpoint: Objective response rate (ORR) assessed by an independent review committee (IRC)

Interventionalopen0 targetStarted 2025-09Completion 2029-04Epizyme, Inc.

Phase I Study to Evaluate Safety and Tolerability of Tazemetostat in Relapsed/Refractory Peripheral T-cell Lymphoma

NCT05983965·Phase 1
Terminated

Primary endpoint: Identify the recommended phase II dose of Tazemetostat

Interventionalopen6 targetStarted 2024-09Completion 2026-031 site · United StatesUniversity of Alabama at Birmingham

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-Cell Lymphoma

NCT05890352·Phase 2
Recruiting

Primary endpoint: Progression-free survival (PFS)

InterventionalRandomizedopen227 targetStarted 2023-09Completion 2029-0150 sites · United StatesSWOG Cancer Research Network

TAZNI: A Phase I/II Combination Trial of Tazemetostat With Nivolumab and Ipilimumab for Children With INI1-Negative or SMARCA4-Deficient Tumors

NCT05407441·Phase 1/Phase 2
Active, not recruiting

Primary endpoint: Incidence of Grade 3 or Higher Treatment-Related Toxicity

Interventionalopen49 targetStarted 2023-08Completion 2029-023 sites · United StatesSusan Chi, MD

Phase I Trial of Tazemetostat in Combination With Venetoclax in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

NCT05618366·Phase 1
Terminated

Primary endpoint: Maximum-tolerated dose (MTD) determination (Part 1)

Interventionalopen3 targetStarted 2023-06Completion 2026-021 site · United StatesWeill Medical College of Cornell University

A Single Arm Phase I/II Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma Big Ten Cancer Research Consortium BTCRC-LYM20-463

NCT05551936·Phase 1/Phase 2

Primary endpoint: Phase I: Evaluate safety and tolerability of tazemetostat with bendamustine and rituximab (BR)

Interventionalopen42 targetStarted 2023-01Completion 2027-055 sites · United StatesVaishalee Kenkre

Phase 2 Study Using Tazemetostat in Patients With Recurrent/Refractory and/or Metastatic Malignant Peripheral Nerve Sheath Tumors (MPNST)

NCT04917042·Phase 2
Active, not recruiting

Primary endpoint: Objective Response Rate

Interventionalopen10 targetStarted 2021-08Completion 2026-121 site · United StatesUniversity of Florida

Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study

NCT04705818·Phase 2
Completed

Primary endpoint: Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A

Interventionalopen164 enrolledStarted 2021-07Completion 2025-073 sites · FranceInstitut Bergonié

A Phase Ia/Ib Study of Talazoparib in Combination With Tazemetostat in Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT04846478·Phase 1
Active, not recruiting

Primary endpoint: Rate of Dose Limiting Toxicity (DLT)

Interventionalopen35 targetStarted 2021-06Completion 2026-122 sites · United StatesDana-Farber Cancer Institute

Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma

NCT04224493·Phase 3·EPZM
Active, not recruiting

Primary endpoint: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)

InterventionalRandomizedquadruple599 targetStarted 2020-06Completion 2029-0350 sites · United StatesEpizyme, Inc.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. ( 1.2 ) Adult patients with relapsed or re(EPZM)FDA ↗
NDA211723Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Who is developing tazemetostat?

tazemetostat is being developed by Epizyme, Inc..

How many clinical trials involve tazemetostat?

BioSniper tracks 16 clinical trials involving tazemetostat.

What is tazemetostat's latest FDA decision?

The most recent tracked FDA decision for tazemetostat is Approval for 1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. ( 1.2 ) Adult patients with relapsed or re, dated January 23, 2020.