Medication Monitor



Generic Name (Trade Name—Company)
Notes
March 1, 2018

Abemaciclib

(Verzenio—Eli Lilly)
Agent approved as initial therapy for HR-positive, HER2-negative metastatic breast cancer

FDA approved abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer.

Approval was based on MONARCH 3, a randomized, double-blinded, placebo-controlled, multicenter clinical trial in postmenopausal women with HR-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 or anastrozole. The estimated median progression-free survival (PFS) (RECIST 1.1) was 28.2 months (95% CI 23.5– not reached) for patients receiving abemaciclib and 14.8 months (95% CI 11.2–19.2) for those receiving placebo (hazard ratio 0.540 [95% CI 0.418–0.698]; P < 0.0001).

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.