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

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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Given the rarity of epithelioid sarcoma, ‘the possibility exists that this trial will not be completed,’ Division of Oncology 3 acting director Steven Lemery said in recommending approval; confirmatory trial is not expected to complete until 2029, and FDA reviewers suggest it may be underpowered to show an effect on progression-free survival. (Part 2 of our Drug Review Profile on the product.)

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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The latest drug development news and highlights from our US FDA Performance Tracker.

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