Epizyme’s Tazemetostat Gains US FDA Panel Nod For Accelerated Approval In Epithelioid Sarcoma
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.
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Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.
Oncologic Drugs Advisory Committee members wondered when Keytruda should be used since cystectomy can be curative and waiting could make the surgery more difficult.