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Advisory Committees Drug Review Regulation

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

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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