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Tazemetostat Approval Status

FDA Approved: No
Generic name: tazemetostat
Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma

Tazemetostat is an oral, first-in-class, EZH2 inhibitor in development for the treatment of patients with metastatic or locally advanced epithelioid sarcoma.

Development Status and FDA Approval Process for tazemetostat

Jul 25, 2019Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma
May 30, 2019Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
Jan  4, 2019Epizyme Announces Registration Path for Tazemetostat for Follicular Lymphoma and Provides Pipeline Updates and 2019 Guidance
Oct 22, 2018Epizyme Reports Positive Data on Tazemetostat in Epithelioid Sarcoma from its Phase 2 Trial Cohort at ESMO
Nov 28, 2016Epizyme Announces Fast Track Designation for Tazemetostat in DLBCL and Provides Solid Tumor Program Update
Jun 19, 2016Epizyme Reports Early Data from Global Phase 2 Trial of Tazemetostat in Non-Hodgkin Lymphoma at ASH Lymphoma Biology Meeting
May  4, 2016Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma

Further information

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