Cel­gene, Agios beat a short path to an FDA de­ci­sion on AML drug

Cel­gene and Agios are floor­ing the gas ped­al in their race to gain a very quick — and ear­ly — ap­proval for enasi­denib (AG-221/CC-90007), their ex­per­i­men­tal ther­a­py for acute myeloid leukemia. Not on­ly did the FDA ac­cept their ap­pli­ca­tion, reg­u­la­tors are pro­vid­ing the in­side track to a new ap­proval with a pri­or­i­ty re­view date that sets the PDU­FA date at the end of Au­gust.

Agios $AGIO de­tailed its plans for tak­ing a di­rect shot at an ear­ly ap­proval last fall, earn­ing a spike from in­vestors as the biotech spot­light­ed the po­ten­tial for tak­ing Phase I/II study da­ta to reg­u­la­tors. Cel­gene re­worked its deal with Agios last year, but kept its hands on its rights to AG-221 in pa­tients with ad­vanced hema­to­log­ic ma­lig­nan­cies with an IDH2 mu­ta­tion.

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