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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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.
ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.