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
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