FDA Advisory Committee recommends tazemetostat as a treatment for metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.- Epizyme Inc.

Epizyme, Inc., announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted 11 - 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery.

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. The New Drug Application (NDA) for tazemetostat, an investigational, oral, first-in-class EZH2 inhibitor, is currently under Priority Review by the FDA with a PDUFA target action date of January 23, 2020.

Epizyme�s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase II study of tazemetostat, which were reported at the 2019 ASCO Annual Meeting.