VERZENIO(abemaciclib)

VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is approved for use in combination with fulvestrant for women with disease progression following endocrine therapy, and as monotherapy for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. The drug received Priority Review status with an application submission and received date of May 5, 2017.

In efficacy trials, abemaciclib plus fulvestrant demonstrated a median progression-free survival (PFS) of 16.4 months, compared to 9.3 months for placebo plus fulvestrant, with a Hazard Ratio (PFS) of 0.55 (95% CI: 0.449, 0.681; p-value <0.0001). The Confirmed Objective Response Rate (ORR) was 19.7% (95% CI: 13.3, 27.5%). For patients in the exemestane arm, the estimated median TTP was 20.3 weeks, while for the megestrol acetate arm, it was 16.6 weeks.

Safety data from the MONARCH 2 study showed 7 deaths in the abemaciclib plus fulvestrant arm and 2 deaths in the placebo plus fulvestrant arm. Specific causes of death in the abemaciclib arm included hepatic function abnormal, lung infection, multiple organ dysfunction syndrome, and pneumonitis, each accounting for 1 death. Additionally, 7 deaths in the abemaciclib arm were attributed to the study disease.