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Priority Review Granted for Abemaciclib in Advanced Breast Cancer

Posted: Wednesday, July 12, 2017

On July 10, Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has accepted and filed its New Drug Application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and given the NDA a Priority Review designation. The NDA includes the company’s submission of abemaciclib for two indications: (1) as monotherapy for patients with hormone receptor–positive, HER2-negative advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and (2) in combination with fulvestrant in women with hormone receptor–positive, HER2-negative advanced breast cancer who had disease progression following endocrine therapy. This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.

In 2015, the FDA granted abemaciclib Breakthrough Therapy designation based on data from the breast cancer cohort expansion of the company’s phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. In addition, Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of 2017.