Bristol/Agios AML’s Idhifa Fails In Phase III, But Approval Seems Secure
Idhifa is already approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses, but did not meet the overall survival endpoint in the Phase III IDHENTIFY.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.