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Tazverik

(TAZEMETOSTAT)

ApprovedSmall molecule

Tazemetostat is used to treat certain types of cancer, particularly follicular lymphoma and epithelioid sarcoma. It works by blocking a protein that helps cancer cells grow and survive.[2] Tazverik is currently approved and in use across 21 indications[4].[1]

Tazverik is one of 322 small molecule programs targeting Malignant Rhabdoid Tumour. It is currently in Approved.

21

Indications

50

Total Trials

23

Active Trials

321

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

27

Patents

Pipeline

Status by Indication[4][1]

Indication

Malignant Rhabdoid TumourApproved

LymphomaSuspended

Malignant Peripheral Nerve Sheath TumorActive, not recruiting

MesotheliomaApproved

Prostate CancerNot yet recruiting

Head and Neck Squamous Cell CarcinomaApproved

Multiple MyelomaRecruiting

Cold Agglutinin DiseaseActive, not recruiting

Advanced CancerRecruiting

McrpcActive, not recruiting

Malignant Rhabdoid TumourApproved

Approved

LymphomaPhase 2

Suspended

Malignant Peripheral Nerve Sheath TumorPhase 2

Active, not recruiting

MesotheliomaApproved

Approved

Prostate CancerPhase 2

Not yet recruiting

Head and Neck Squamous Cell CarcinomaApproved

Approved

Multiple MyelomaPhase 2

Recruiting

Cold Agglutinin DiseasePhase 3

Active, not recruiting

Advanced CancerPhase 1

Recruiting

McrpcPhase 1

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

370 competitors in Lymphoma

#DrugCompanyPhaseTrials

Tazverik

Zofran

Norvir

Cabenuva

Nuvigil

NNuvo Research GmbH

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Phase 2Active, not recruiting

Recurrent Endometrial Endometrioid Adenocarcinoma

NCT03348631

Phase 1/2Not yet recruiting

Lymphoma

NCT07209163

Q2 2027

Phase 1/2Active, not recruiting

Follicular Lymphoma

NCT05551936

Phase 1Active, not recruiting

Recurrent B-Cell Non-Hodgkin Lymphoma

NCT05627245

PreclinicalActive, not recruiting

Locally Advanced Urothelial Carcinoma

NCT03854474

Clinical

Trials by Indication[1]

Lymphoma10 trials

Tazemetostat in Treating Patients With Metastatic or Unresectable Solid Tumors or B-Cell Lymphomas With Liver Dysfunction

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT03217253

Tazemetostat Plus CHOP in 1L T-cell Lymphoma

Suspended·—·Phase 2·NCT06692452·24 enrolled

Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Recruiting·WWeill Medical College of Cornell University·Phase 1·NCT05618366·38 enrolled

Show 7 more trials

Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

Completed· Eisai logo

Eisai·Phase 2·NCT03456726·20 enrolled

A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Completed· Eisai logo

Eisai·Phase 1·NCT03009344·7 enrolled

A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma

Completed·HHutchmed·Phase 2·NCT05713110·61 enrolled

Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

Completed·EEpizyme, Inc.·Phase 1·NCT03028103·32 enrolled

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL

Completed·EEpizyme, Inc.·Phase 1/2·NCT01897571·400 enrolled

Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma

Not yet recruiting·RRuijin Hospital·Phase 1/2·NCT07209163·48 enrolled

A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP

Active, not recruiting·TThe Lymphoma Academic Research Organisation·Preclinical·NCT02889523·214 enrolled

Follicular Lymphoma6 trials

Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

Suspended·—·Phase 2·NCT06575686·33 enrolled

Zandelisib + Tazemetostat in R/R Follicular Lymphoma

Withdrawn·JJacob Soumerai, MD·Phase 1/2·NCT05604417

Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

Completed·HHutchmed·Phase 2·NCT05467943·42 enrolled

Show 3 more trials

A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japan

Active, not recruiting· Eisai logo

Eisai··NCT05228158·145 enrolled

A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma

Active, not recruiting·VVaishalee Kenkre·Phase 1/2·NCT05551936·42 enrolled

Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma

Withdrawn·—·Phase 1/2·NCT05152459

Epithelioid Sarcoma3 trials

Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Terminated·EEpizyme, Inc.·Phase 1·NCT04204941·25 enrolled

Tazemetostat Expanded Access Program for Adults With Solid Tumors

No longer available·EEpizyme, Inc.··NCT03874455

Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma

No longer available·EEpizyme, Inc.··NCT04225429

Prostate Cancer2 trials

A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer

Not yet recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT07407283·100 enrolled

A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer

Terminated·EEpizyme, Inc.·Phase 1/2·NCT04179864·102 enrolled

Blood Cancer1 trial

A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

Withdrawn·EEpizyme, Inc.·Phase 1/2·NCT05205252

28 more indications

Lymphoid Malignancies1 trial

Study of Tazemetostat in Lymphoid Malignancies

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT05983965·30 enrolled

Advanced Cancer1 trial

A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function

Recruiting·EEpizyme, Inc.·Phase 1·NCT04241835·24 enrolled

mCRPC1 trial

Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC

Active, not recruiting·—·Phase 1·NCT04846478·35 enrolled

Solid Tumors1 trial

Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation

Terminated·PPrisma Health-Upstate·Phase 2·NCT05023655·20 enrolled

Tic Disorder1 trial

Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03213665·20 enrolled

COVID-191 trial

Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection

Withdrawn·LLoma Linda University·Phase 2·NCT05018975

Malignant Mesothelioma1 trial

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma

Completed·EEpizyme, Inc.·Phase 2·NCT02860286·74 enrolled

Cancer1 trial

Combining Epigenetic And Immune Therapy to Beat Cancer.

Completed·IInstitut Bergonié·Phase 2·NCT04705818·164 enrolled

Induction Chemotherapy1 trial

Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma

Not yet recruiting·—·Phase 2·NCT05151588·30 enrolled

Recurrent or Metastatic1 trial

Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Terminated·WWashington University School of Medicine·Phase 1·NCT04624113·13 enrolled

Multiple Myeloma1 trial

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT05372354·260 enrolled

Soft Tissue Sarcoma1 trial

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma

Completed·EEpizyme, Inc.·Phase 2·NCT02601950·267 enrolled

R/R AML1 trial

Tazemetostat and Palbociclib With CPX-351for R/R AML

Recruiting·TThomas Jefferson University·Phase 1·NCT05627232·24 enrolled

Synovial Sarcoma1 trial

EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Completed·EEpizyme, Inc.·Phase 1·NCT02601937·109 enrolled

Tumors1 trial

Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors

Recruiting·—·Phase 1/2·NCT05407441·49 enrolled

Diffuse Large B-Cell Lymphoma1 trial

A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

Completed· Roche logo

Roche·Phase 1·NCT02220842·96 enrolled

Malignant Peripheral Nerve Sheath Tumor1 trial

Tazemetostat in Malignant Peripheral Nerve Sheath Tumors

Active, not recruiting·UUniversity of Florida·Phase 2·NCT04917042·10 enrolled

Grade 3b Follicular Lymphoma1 trial

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

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05890352·227 enrolled

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

Terminated·EEpizyme, Inc.·Preclinical·NCT02875548·58 enrolled

Recurrent Endometrial Endometrioid Adenocarcinoma1 trial

A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03348631·62 enrolled

Relapsed/Refractory Follicular Lymphoma1 trial

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

Active, not recruiting·EEpizyme, Inc.·Phase 3·NCT04224493·599 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

Phase 1/Expansion Study of Tazemetostat Plus Belinostat for the Treatment of Relapsed or Refractory Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05627245·48 enrolled

B-cell Non Hodgkin Lymphoma1 trial

Phase II, Single Arm, Open Label, Study of the Combination of Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-Cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

Active, not recruiting·NNorthwestern University·Phase 2·NCT06242834·11 enrolled

Locally Advanced Urothelial Carcinoma1 trial

A Pilot Study of Tazemetostat and Pembrolizumab (MK-3475) in Advanced Urothelial Carcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT03854474·30 enrolled

Advanced Malignant Solid Neoplasm1 trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

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 (TARZAN Trial)

Active, not recruiting·UUniversity of Utah·Phase 1·NCT06824701·24 enrolled

Cold Agglutinin Disease1 trial

CADENZA-EXT: Sutimlimab in Cold Agglutinin Disease

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT04762160·78 enrolled

Unspecified1 trial

Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

Completed·EEpizyme, Inc.·Phase 1·NCT04537715·42 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 23, 2020

TAZVERIK

NDA NDA211723

Jan 23, 2020

TAZVERIK

NDA NDA211723

Nov 16, 2023

TAZVERIK

NDA NDA211723

Aug 13, 2024

TAZVERIK

NDA NDA211723

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for TAZEMETOSTAT. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tazverik drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — TAZEMETOSTAT compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for TAZEMETOSTAT. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211723). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tazverik. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Epizyme, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histone-Lysine N-Methyltransferase EZH2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EEpizyme, Inc.

Patent Landscape[6]

Patent Cliff

Sep 12, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9949999Sep 12, 2031

12161645Sep 12, 2031

12168016Sep 12, 2031

12168015Sep 12, 2031

9549931Sep 12, 2031

22 more patents

9855275Sep 12, 2031

10420775Sep 12, 2031

9090562Sep 12, 2031

11052093Sep 12, 2031

8765732Sep 12, 2031

9334527Sep 12, 2031

9333217Sep 12, 2031

8691507Sep 12, 2031

10155002Sep 12, 2031

9175331Sep 12, 2031

8895245Sep 12, 2031

10821113Apr 11, 2033

10245269Apr 11, 2033

9394283Apr 11, 2033

11491163Apr 11, 2033

8410088Jan 23, 2034

12162865Jun 12, 2034

9688665Aug 22, 2034

10369155Oct 16, 2035

9889138Oct 16, 2035

10786511Dec 19, 2035

12168014May 3, 2038

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