Verzenio Receives New Indication as Initial Treatment for Metastatic Breast Cancer

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates


On February 26, 2018, the FDA approved a new indication for abemaciclib (Verzenio; Eli Lilly), a CDK4/CDK6 inhibitor, alone or in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

“This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumor size and delayed disease progression in women with hormone receptor-positive, HER-2-negative metastatic breast cancer,” said Joyce O’Shaughnessy, MD, Chair of the Breast Cancer Research Program at Baylor University Medical Center, TX, in a press release. “This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer.”

Abemaciclib was first approved in September 2017, as monotherapy for adults with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy and chemotherapy in the metastatic setting, or in combination with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy.

The FDA approved this new indication based on updated results from MONARCH 3, a phase 3, randomized clinical trial that randomized 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The median progression-free survival was 28.2 months with abemaciclib plus an aromatase inhibitor versus 14.8 months with placebo (hazard ratio, 0.54; P <.0001). The median duration of response was 27.4 months in the abemaciclib arm versus 17.5 months in the placebo arm (95% confidence interval, 25.7-NR vs 11.2-22.2, respectively).

The most common adverse reaction in the abemaciclib arm was diarrhea (81%). Other common side effects were neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, and leukopenia.