Treats metastatic or locally advanced epithelioid sarcoma not eligible for complete…. NDA 211723, held by Epizyme Inc. Tazemetostat Hydrobromide.
As of Nov 13, 2026, NDA 211723 (Tazverik), held by Epizyme Inc, was first approved by FDA on Jan 23, 2020, with 2 approved supplements and 0 published complete response letters.
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. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TazverikEQ 200MG BASE · tablet;oral | Tazemetostat Hydrobromide | DiscontinuedReference drug |
| Aug 13, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Nov 16, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Jan 23, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
