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Tazverik FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved January 23, 2020)
Brand name: Tazverik
Generic name: tazemetostat
Dosage form: Tablets
Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma; Follicular Lymphoma

Tazverik (tazemetostat) is a methyltransferase inhibitor 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.
  • 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.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Development Timeline for Tazverik

DateArticle
Jun 18, 2020Approval  Epizyme Announces U.S. FDA Accelerated Approval of Tazverik (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
Jan 23, 2020Approval  FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
Dec 18, 2019Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
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

Further information

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