FDA Expands Abemaciclib Indication as Initial Therapy for Advanced Breast Cancer

The FDA previously approved abemaciclib for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy.

The FDA has approved abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

The approval was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.

In the phase III study, the median progression-free survival was 28.2 months (95% CI, 23.5 to not reached) in the abemaciclib arm versus 14.8 months (95% CI,11.2-19.2) with the NSAI alone (HR, 0.54; 95% CI, 0.418-0.698; P <.0001). In those with measurable disease, the objective response rate (ORR) was 55.4% with the CDK4/6 inhibitor and 40.2% in the control arm.

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