FDA pulls
FDA pulls TAZVERIK approval for epithelioid sarcoma patients
The company asked FDA to remove the 200-mg tablet from the market after safety concerns surfaced in a confirmatory trial. The withdrawal took effect June 22, 2026.
FDA is withdrawing approval of Epizyme’s TAZVERIK tablet, 200 milligrams, effective June 22, 2026. The drug had been approved for adults and patients 16 and older with metastatic or locally advanced epithelioid sarcoma.
- FDA withdrew approval of TAZVERIK 200 mg on June 22, 2026.
- Epizyme requested the withdrawal and waived expedited procedures.
- The drug had been approved for metastatic or locally advanced epithelioid sarcoma.
- Patients and clinicians now have one fewer approved option in this cancer.
- Patients with metastatic or locally advanced epithelioid sarcoma have one fewer FDA-approved option
Patients with metastatic or locally advanced epithelioid sarcoma have one fewer FDA-approved option. In Washington, the Food and Drug Administration said it is withdrawing approval of TAZVERIK, the 200-milligram tazemetostat tablet held by Epizyme, an Ipsen company, effective June 22, 2026.
The drug had been approved on Jan. 23, 2020 under accelerated approval for adults and pediatric patients 16 and older whose disease was not eligible for complete resection. Epizyme voluntarily requested the withdrawal and waived expedited withdrawal procedures.
The approval is gone
TAZVERIK was not pulled because FDA opened a new enforcement action or narrowed the label. The approval itself is being withdrawn, which means the product no longer has federal authorization for the approved use. The notice traces that decision back to NDA 211723, the application that brought TAZVERIK onto the market through accelerated approval.
The notice also says distribution of the tablet in interstate commerce without an approved application is illegal. For pharmacies and distributors, that is the line that now matters.
For cancer care, the practical loss
For oncologists and families facing epithelioid sarcoma, the immediate effect is fewer approved treatment choices. The withdrawn use was specific: metastatic or locally advanced epithelioid sarcoma in adults and patients 16 and older who were not eligible for complete resection.
The notice does not say what, if anything, replaces the drug for those patients, and it does not spell out Epizyme’s business or clinical reasoning beyond the company’s request.