FDA Withdraws Approval for TAZVERIK 200 mg Tablets
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The FDA is withdrawing approval for TAZVERIK 200 mg tablets, a cancer drug made by Epizyme, an Ipsen company. The withdrawal takes effect on June 22, 2026, after the company voluntarily asked the FDA to withdraw the drug’s application and waived faster withdrawal procedures. TAZVERIK had received accelerated approval for certain patients with advanced epithelioid sarcoma and relapsed or refractory follicular lymphoma. Those approvals depended on follow-up studies confirming clinical benefit. Epizyme later reported a higher rate of second primary cancers in a required confirmatory trial, making this notice important for oncology providers, patients using or considering the drug, pharmacies, and compliance teams in the pharmaceutical sector.
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Key Changes
- FDA withdraws approval of NDA 211723 for TAZVERIK 200 mg tablets.
- The withdrawal takes effect on June 22, 2026.
- The action follows Epizyme’s voluntary request and safety concerns reported in a required confirmatory trial.
Obligations
What this law requires
Epizyme, Inc. no longer has FDA approval for NDA 211723 for TAZVERIK (tazemetostat) 200 mg tablets as of the withdrawal effective date.
TAZVERIK (tazemetostat) 200 mg tablets must not be treated as FDA-approved for the previously accelerated-approved indications after the withdrawal of NDA 211723.