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

 
• By Sue Sutter

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.

Risks verses benefits
US FDA questions about the adequacy of efficacy evidence for tazemetostat come amid concerns about the risk of secondary malignancies. • Source: Shutterstock

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