Epizyme announces FDA advisory committee meeting to review NDA for tazemetostat
Epizyme announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration is scheduled to review data supporting the company's New Drug Application, or NDA, requesting accelerated approval for tazemetostat, an oral, first-in-class EZH2 inhibitor, at a meeting on Dec. 18, 2019 at 1:00 p.m. ET. The proposed indication to be discussed at this upcoming ODAC meeting is for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. "ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of a product is made solely by the FDA. Epizyme announced on July 25, 2019 that the FDA had accepted for filing the NDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery with Priority Review and a Prescription Drug User-Fee Act action date of Jan. 23, 2020. Epizyme's NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat," the company stated.