Celgene, Agios Ready For Enasidenib Launch After Early Approval
Executive Summary
Idhifa is the first treatment for AML patients with IDH2 mutations. The drug will be co-commercialized by Celgene and Agios under their 2010 collaboration and is the latter's first regulatory approval.
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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.
Bristol/Agios AML Drug Idhifa Fails In Phase III
Idhifa is 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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