Abemaciclib Received FDA Approval for Initial Treatment of Hormone-Positive Stage 4 Breast Cancer

On 26 February 2018, the FDA approved, for hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women, the drug abemaciclib (brand name Verzenio) together with hormonal therapy.

The approval is based on HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women studied in the randomized, double-blind, placebo-controlled, multicenter MONARCH 3 clinical trial . A total of 493 patients were divided into two groups in a 2-to-1 ratio. One group received, in addition to hormonal therapy (the aromatase inhibitors letrozole or anastrozole), abemaciclib; the other received hormonal therapy plus placebo (a drug containing no active ingredient).

In the Study, Median Disease Control with Treatment (Progression-Free Survival) Was 28.2 Months with Abemaciclib, Compared with 14.8 Months with Placebo.

In MONARCH 3, at least 20% of abemaciclib recipients reported side effects including diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia (low blood count), vomiting, alopecia (hair loss) and reduced appetite.

When abemaciclib is combined with an aromatase inhibitor, the recommended starting dose is 150 mg twice daily, with or without food.

Abemaciclib previously received FDA approval for use with fulvestrant in patients with stage 4 breast cancer progressing after hormonal treatment—as second-line treatment—on 28 September 2017.

What Is the Mechanism of Action of Abemaciclib (Verzenio)?

Abemaciclib blocks cyclin-dependent kinase 4/6, part of intracellular growth signaling pathways in cancer cells. Palbociclib (Ibrance) and ribociclib (Kisqali) were followed by abemaciclib, a third-generation cyclin-dependent kinase 4/6 inhibitor, which also received FDA approval for breast cancer treatment.

Related Topic:

• Growth factors and cancer