# 2026-12367: FDA Pulls Approval of TAZVERIK Cancer Drug

2026-12367, Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-22, effective 2026-06-22; PRIA reads it as touching household money (as of 2026-06-29).

- Canonical: https://policyrisk.com/federal-register/2026-12367
- As of: 2026-06-29
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12367
- Title: Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 37120
- Published: 2026-06-22
- Effective: 2026-06-22
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-29

## In one line

FDA Pulls Approval of TAZVERIK Cancer Drug

## 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.

## Abstract

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for TAZVERIK (tazemetostat) tablet, 200 milligrams (mg), held by Epizyme, Inc., an Ipsen Company (Epizyme), 1 Main St., Cambridge, MA 02142. Epizyme has voluntarily requested withdrawal of its NDA and has waived the expedited withdrawal procedures.

## Effects PRIA read

- TAZVERIK approval withdrawn June 22, 2026: cost, high. 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 res…
- Insurance and treatment access may change: cost, medium. Because approval was withdrawn as of June 22, 2026, coverage and access to TAZVERIK by insurers or pharmacies may change.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: cost, medium. 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.
- Safety signal in confirmatory trial: mixed, high. 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.

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## Sources
- [2026-12367 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/22/2026-12367/epizyme-inc-withdrawal-of-approval-of-new-drug-application-for-tazverik-tazemetostat-tablet-200)
- [2026-12367 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12367.pdf)

## Related
- [Previous: 2026-12366, Notice Pursuant to the National Cooperative Research and Production Act of 1993…](https://policyrisk.com/federal-register/2026-12366)
- [Next: 2026-12368, Agency Information Collection Activities; Submission for OMB Review; Comment Re…](https://policyrisk.com/federal-register/2026-12368)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12367 (as of 2026-06-29).