FDA Approval Alert: New Therapy for Type of Advanced Breast Cancer


The US Food and Drug Administration (FDA) has approved a therapy to treat adults with advanced, metastatic breast cancer that has progressed on endocrine therapy.

Abemaciclib (Verzenio, Eli Lilly) is now indicated for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is to be given in combination with fulvestrant or alone (if patient was previously treated with endocrine therapy and chemotherapy after metastasis).

FDA approval in combination with fulvestrant came following the results of a trial in which 669 patients were sampled. Median progression-free survival for patients taking abemaciclib with fulvestrant was 16.4 months compared to 9.3 months for patients taking a placebo plus fulvestrant.


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FDA approval as a stand-alone therapy came following the results of a trial in which 132 patients were sampled. Objective response rate was 19.7% for a median of 8.6 months for patients taking abemaciclib.

Adverse events associated with abemaciclib include diarrhea, neutropenia, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache.—Zachary Bessette