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Epizyme’s Tazemetostat Faces US FDA Doubts About Efficacy In Epithelioid Sarcoma

Executive Summary

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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