Epizyme, Inc. was granted accelerated approval of TAZVERIK (tazemetostat) from the U.S. FDA for the treatment of metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase II trial.

The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients received TAZVERIK 800 mg orally twice daily until disease progression or unacceptable toxicity. The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR). In the total 62 patients treated, the ORR (95% confidence interval) was 15% (7%, 26%), with 1.6% of patients achieving a complete response and 13% achieving a partial response. Among responders in the trial, 67% had a duration of response of six months or longer.

“Today’s accelerated approval of TAZVERIK is a landmark event for people with ES and represents our dedication to our mission of rewriting treatment for people with cancer and other serious diseases,” said Robert Bazemore, president and chief executive officer of Epizyme. “TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days.”