On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that trading of its common stock has been halted (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552484]). The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting at 8:00 a.m. ET today to discuss Epizyme’s New Drug Application (NDA) for tazemetostat, an oral, first-in-class EZH2 inhibitor, for the treatment of patients with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for curative surgery.

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Epizyme’s NDA submission is based primarily on data from the 62 patient ES cohort of its ongoing Phase 2 study of tazemetostat. The ODAC is scheduled to start at 8:00 a.m. ET. The briefing materials can be found on FDA’s website here. Tazemetostat was submitted under the Accelerated Approval pathway and is under Priority Review with FDA, with an assigned Prescription Drug User Fee Act (PDUFA) date of Jan. 23, 2020.

Today’s advisory committee vote will be non-binding, but FDA takes its recommendations into consideration when reviewing related applications for marketing approval.