FDA Expands Approval of Breast Cancer Therapy


The US Food and Drug Administration (FDA) has granted approval to a therapy in combination with an aromatase inhibitor for the treatment of a specific type of advanced breast cancer.

Abemaciclib (Verzenio, Eli Lilly) is now approved in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

The additional FDA approval is the third indication for abemaciclib in 5 months. Abemaciclib was originally approved in September 2017 in combination with fulvestrant for progressed breast cancer following endocrine therapy.

Expanded approval for abemaciclib came following results of a late-stage study in with abemaciclib twice-daily with either anastrozole or letrozole demonstrated significantly delayed disease progression compared with a placebo in combination with either of the aromatase inhibitors.


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"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 HR+, HER2- metastatic breast cancer,” said Joyce O'Shaughnessy, MD, Celebrating Women Chair in Breast Cancer Research and chair, Breast Cancer Research Program, Baylor University Medical Center, Texas Oncology and US Oncology, (Dallas, TX), in a press release (February 26, 2018). "This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer."—Zachary Bessette