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Ribociclib Receives FDA Breakthrough Therapy Designation for Treatment of Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib in combination with letrozole for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is a selective cyclin-dependent kinase (CDK4/6) inhibitor.

The Breakthrough Therapy designation is based primarily on positive results of the phase III MONALEESA-2 trial of ribociclib in combination with letrozole in postmenopausal women who had received no prior therapy for their advanced disease. The MONALEESA-2 trial met the primary endpoint of clinically meaningful improvement in progression-free survival at a preplanned interim analysis. Results of this study will be presented at an upcoming medical congress and will form the basis of regulatory discussions in the United States, Europe, and other countries for use in this indication.

“Despite advancements in treatment, an estimated 40,000 individuals in the United States die each year from advanced breast cancer,” said Alessandro Riva, MD, Global Head, Oncology Development and Medical Affairs at Novartis Oncology, the manufacturer of ribociclib. “This designation shows the potential of ribociclib, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with [hormone receptor–positive], HER2-negative advanced breast cancer as quickly as possible.”

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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