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Priority Review Granted by FDA for Abemaciclib as First-Line Treatment for Advanced Breast Cancer

By: Sarah Jackson
Posted: Monday, October 16, 2017

The U.S. Food and Drug Administration (FDA) recently granted Priority Review designation for abemaciclib (Verzenio) as a first-line treatment for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as reported in an announcement by Lilly on October 12, 2017. The designation was granted based on the results of the MONARCH 3 study, which were presented at the European Society for Medical Oncology (ESMO) 2017 Congress, as well as recently published in the Journal of Clinical Oncology. Abemaciclib has been indicated in combination with fulvestrant in patients with hormone receptor–positive, HER2-negative breast cancer whose disease progressed following endocrine therapy.

The MONARCH 3 trial included nearly 500 patients from 22 countries who had never been treated for metastatic disease. The objective response rate in those with measurable disease was 59% with abemaciclib versus 44% with endocrine therapy alone. The median progression-free survival was not reached in the abemaciclib arm, but the results showed approximately a 46% reduction in the relative risk.

As seen in the MONARCH 2 trial, the most common adverse reactions for those treated with abemaciclib plus fulvestrant compared with those treated with placebo plus fulvestrant were diarrhea (86% vs 25%) and neutropenia (46% vs 4%).