Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer

On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: abemaciclib monotherapy for patients with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who have received prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant (Faslodex) 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.

Lilly is working closely with the FDA and anticipates agency action on this application in the first quarter of 2018.

“We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy [with fulvestrant] for patients with advanced breast cancer,” said Levi Garraway, MD, PhD, Senior Vice President, Global Development and Medical Affairs, Lilly Oncology. “Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden. We look forward to working with the FDA and bringing this important potential treatment option to patients as soon as possible.”

In 2015, the FDA granted abemaciclib Breakthrough Therapy designation based on data from the breast cancer cohort expansion of the phase I JPBA trial, 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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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