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Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Executive Summary

Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

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Tazverik Accelerated Approval: Disease Rarity And Unmet Need Won Out Over Efficacy Concerns

US FDA reviewers recommended against accelerated approval of Epizyme’s tazemetostat for epithelioid sarcoma, finding the modest overall response rates were not substantial evidence of an improvement over available therapies; they were overruled by senior oncology review staff, who cited a unanimous ODAC endorsement and the regulatory flexibility encouraged for rare diseases.

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