Updated: Celgene, Agios win a landmark FDA OK for new AML drug Idhifa
Celgene and Agios didn’t have to wait until the PDUFA date at the end of August to get a speedy FDA decision on enasidenib (AG-221), their new therapy for acute myeloid leukemia. The FDA cut to the chase and approved it today.
Celgene $CELG reworked its deal with Agios $AGIO last year, but kept its hands on its rights to AG-221 in patients with advanced hematologic malignancies with an IDH2 mutation. In turn, Agios stayed razor focused on grabbing the earliest possible approval, hustling Phase I/II data straight to regulators for an accelerated review.
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