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Bristol/Agios AML’s Idhifa Fails In Phase III, But Approval Seems Secure

 
• By Mandy Jackson

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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Idhifa missed the overall survival endpoint in Phase III

Bristol-Myers Squibb Company’s IDH2 inhibitor Idhifa (enasidenib) did not meet the primary endpoint of overall survival (OS) in the Phase III IDHENTIFY clinical trial in patients with relapsed or refractory acute myeloid leukemia, but the result may not imperil its marketing status since the product has already received received full, not accelerated approval, from the FDA.

Idhifa was approved in the US in 2017 for adults with relapsed or refractory AML with IDH2 mutations. Agios...

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