FDA Pulls Approval of TAZVERIK Cancer Drug
Published Date: 6/22/2026
Notice
Summary
Epizyme, Inc. has asked the FDA to withdraw approval for their cancer drug TAZVERIK (200 mg tablets), effective June 22, 2026. This means TAZVERIK will no longer be officially approved for treating certain sarcomas and lymphomas, affecting patients and healthcare providers relying on it. The change might impact treatment options and insurance coverage, so folks should check with their doctors about next steps.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
TAZVERIK approval withdrawn June 22, 2026
The FDA withdrew approval of NDA 211723 for TAZVERIK (tazemetostat) 200 mg tablets effective June 22, 2026. TAZVERIK will no longer be an FDA‑approved treatment for adults and pediatric patients 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, nor for the two follicular lymphoma indications approved June 18, 2020.
Safety signal in confirmatory trial
Epizyme notified FDA on March 6, 2026, of an increased rate of second primary malignancies in the TAZVERIK arm of the SYMPHONY-1 (EZH-302) confirmatory trial. That safety finding was a reason cited for withdrawing approval of the drug.
Insurance and treatment access may change
Because approval was withdrawn as of June 22, 2026, coverage and access to TAZVERIK by insurers or pharmacies may change. If you or someone is being treated with TAZVERIK, check with your doctor and insurer about next steps and coverage options.
Post‑withdrawal sales are illegal
After approval was withdrawn on June 22, 2026, distribution of TAZVERIK 200 mg tablets into interstate commerce without an approved application is illegal and subject to regulatory action under the FD&C Act. Epizyme also withdrew TAZVERIK from marketing in the United States.
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