On September 28, 2017, a few weeks after ESMO 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), in combination with fulvestrant, for the treatment of adults with advanced or metastatic HR-positive, HER2-negative breast cancer that progressed after endocrine therapy, or as monotherapy after endocrine therapy and chemotherapy in the metastatic setting.
“Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.
Soon after this initial FDA approval, in early October 2017, the FDA granted a priority review status for a New Drug Application for abemaciclib—as first-line therapy for the same patient population, based on the results of the MONARCH 3 study, which were presented at ESMO 2017.
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MONARCH 3: Adding Abemaciclib to an Aromatase Inhibitor Improves Outcomes in Metastatic Breast Cancer
The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor abemaciclib (Verzenio) to an aromatase inhibitor improved progression-free survival (PFS) over aromatase inhibitor monotherapy in women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to an interim analysis of the phase 3 MONARCH 3 clinical trial presented at the 2017 European Society for Medical Oncology (ESMO) Congress. The study was also recently published in the Journal of Clinical Oncology.
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