Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.
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The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
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.
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.