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Lilly's Abemaciclib Hit Leaves It Down But Not Out

 
• By Emily Hayes

Continuation of Phase III MONARCH 2 study, with no early termination for efficacy, may mean a delay in filing and a tougher competitive outlook against Pfizer's Ibrance and Novartis' ribociclib.

Not only does Eli Lilly & Co.'s announcement that its breast cancer drug abemaciclib did not show enough efficacy to terminate the pivotal MONARCH 2 study early throw its filing plans into doubt, it may also dash the commercial prospects for the cyclin-dependent kinase (CDK)4/6 inhibitor, which now seems destined to be third to market.

Hopes for an early filing of abemaciclib were dashed on Aug. 10, when Lilly announced that the MONARCH 2 study, which included 669 patients, would continue after a preplanned interim...

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