Advisory Committee Supports Epizyme’s NDA for Epithelioid Sarcoma

The FDA’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of Epizyme’s tazemetostat for treatment of metastatic or locally advanced epithelioid sarcoma not eligible for surgery.

If approved, the oral drug will offer patients with the rare, aggressive form of cancer a possible alternative to intravenous chemotherapy or radiation with potentially fewer side effects.

The 11-member committee voted to recommend the drug based on data from a multicenter trial of 62 patients. The overall response rate was 15 percent, with an overall survival of 82.4 weeks.