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The FDA has accepted and filed the New Drug Application (NDA) for abemaciclib, a CDK4/6 inhibitor, and given the NDA a Priority Review designation.

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This includes the submission of abemaciclib for two indications: 1) abemaciclib monotherapy for patients with HR+, HER2- advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and 2) abemaciclib in combination with fulvestrant in women with HR+, HER2- 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 phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. A drug that receives this designation may be eligible for Priority Review, which aims to expedite the review of drugs that, if approved, would represent a significant advance in treatment. The FDA's goal is to take action within 8 months of receiving an application, compared with the standard review time frame of 12 months.