Epizyme’s Tazemetostat Faces US FDA Doubts About Efficacy In Epithelioid Sarcoma
Low response rates in open-label, nonrandomized study raise questions about efficacy of the first-in-class EZH2 inhibitor relative to drugs currently used to treat the rare cancer, FDA says in advisory committee briefing document; retrospective natural history study also cannot be used to determine whether patients have better outcomes with tazemetostat than with available therapies.
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Real-World Evidence: Epizyme’s Epithelioid Sarcoma Natural History Study Falls Flat At US FDA
Sponsor had hoped to use retrospective case review study as an external control arm to support regular approval of tazemetostat; US FDA not only rejected this idea, it found the study design so flawed that it did not consider the results in its efficacy assessment for accelerated approval.
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.
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.