FDA Approves Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer

On February 26, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.


Approval was based on the MONARCH 3 trial, a randomized (2:1), double-blinded, placebo-controlled, multicenter clinical trial in postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. A total of 493 patients were randomized to receive either abemaciclib 150 mg or placebo orally twice daily plus physician’s choice of letrozole (Femara) or anastrozole. The estimated median progression-free survival (PFS) (RECIST 1.1) was 28.2 months (95% confidence interval [CI] = 23.5 to not reached) for patients receiving abemaciclib and 14.8 months (95% CI = 11.2–19.2) for those receiving placebo (hazard ratio [HR] = 0.540; 95% CI = 0.418–0.698; P < .0001).

The most common adverse reactions in at least 20% of patients receiving abemaciclib in MONARCH 3 and more than 2% higher than the placebo arm were diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, and leukopenia.

The recommended starting dose of abemaciclib in combination with an aromatase inhibitor is 150 mg twice daily orally with or without food.

Full prescribing information is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208855s000lbl.pdf.

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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