FDA Grants Priority Review for Abemaciclib as Initial Treatment of Advanced Breast Cancer

On October 12, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its New Drug Application (NDA) for abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor.

MONARCH 3

The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor–positive, HER2–negative advanced or metastatic breast cancer. The results were presented by Di Leo et al at the European Society for Medical Oncology (ESMO) 2017 Congress (Abstract 236O_PR) and recently published by Goetz et al in the Journal of Clinical Oncology.

“On the heels of our recent FDA approval of [abemaciclib], we are pleased with this important step forward in the agency’s consideration to expand the use of [abemaciclib] in metastatic breast cancer,” said Levi Garraway, MD, PhD, Senior Vice President, Global Development and Medical Affairs, Lilly Oncology. “We look forward to ongoing collaboration with the FDA to advance this important treatment across the spectrum of care for patients living with advanced or metastatic breast cancer.”

Priority Review aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment. With Priority Review of a new drug, 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.

In the third quarter of 2017, Lilly completed European Union and Japan regulatory submissions for abemaciclib.

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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