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Agios, Celgene Target Accelerated Approvals For Precision AML Medicines

 
• By Mandy Jackson

Celgene Corp. will pursue accelerated approval later this year for AG-221 (enasidenib), the lead drug candidate under its partnership with Agios Pharmaceuticals Inc., which may separately seek accelerated approval for its wholly-owned drug AG-120 in 2017, giving Agios's precision medicines a foothold in the oncology market while the collaborators work to expand the labeling for their drugs.

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Celgene Corp. will pursue accelerated approval later this year for AG-221 (enasidenib), the lead drug candidate under its partnership with Agios Pharmaceuticals Inc., which may separately seek accelerated approval for its wholly-owned drug AG-120 in 2017, giving Agios's precision medicines a foothold in the oncology market while the collaborators work to expand the labeling for their drugs.

Cambridge, Massachusetts-based Agios said in a Sept. 7 US Securities and Exchange Commission (SEC) filing that the companies will seek US FDA approval for both AG-221 and AG-120 for the treatment of relapsed or refractory acute myelogenous leukemia (AML) based on early-stage clinical data

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