Epizyme’s Tazemetostat Gains US FDA Panel Nod For Accelerated Approval In Epithelioid Sarcoma

 
• By Sue Sutter

Unanimous approval recommendation driven by data on durable responses and disease stability, although some advisory committee members suggest limiting indication to second-line use; FDA comments suggest concerns about design and feasibility of planned confirmatory trial.

FDA Advisory Committee Feature image
Oncologic Drugs Advisory Committee voted unanimously that tazemetostat's benefits outweigh its risks.

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