Eli Lilly’s Verzenio has been given another green light in the US for breast cancer, significantly expanding the drug’s treatment scope.

The US Food and Drug Administration (FDA) has approved use of Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as 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 indication marks the third to be cleared in five months, following its initial nod in September last year as the first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved in combination and as a single agent for metastatic breast cancer.

Verzenio’s expanded approval rides on the back of efficacy and safety from the pivotal MONARCH 3 clinical trial, in which patients dosed orally with the drug at 150mg twice daily on a continuous schedule with an AI showed a greater median progression-free survival (PFS) than those receiving initial endocrine-based therapy plus placebo (28.2 months vs 14.8 months, respectively).

In patients with measurable disease who received Verzenio plus an AI, an objective response rate of 55.4 percent was achieved, compared to 40.2 percent for placebo-plus-AI treated patients.

"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,” noted Joyce O'Shaughnessy, Celebrating Women Chair in Breast Cancer Research and chair, Breast Cancer Research Program, Baylor University Medical Center, Texas Oncology and US Oncology.

On the safety side, the drug’s label contains warnings and precautions for diarrhea, neutropenia, hepatotoxicity, venous thromboembolism, and embryofetal toxicity.