Verzenio Approved for Postmenopausal Women with HR+, HER2- Advanced Breast Cancer
The U.S. Food and Drug Administration approved Eli Lilly's Verzenio (abemaciclib) in combination with an aromatase inhibitor as an initial treatment for postmenopausal women with advanced breast cancer.
Verzenio is for breast cancer tumors that are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-).
This is the third approval Verzenio has received in a five-month period, significantly expanding the drug's treatment scope.
The treatment is a dual inhibitor of the cyclin-dependent kinases (CDK) 4 and 6. CDKs regulate cell proliferation and growth, and CDK4/6 specifically are often highly elevated in breast cancer, fueling the uncontrolled proliferation of cancer cells.
The FDA's decision was supported by the positive results from the Phase 3 MONARCH trial (NCT02246621), which evaluated whether Verzenio delayed the time until disease progression in postmenopausal women with HR+, HER2- advanced breast cancer and had not had previous systemic therapy.
The study enrolled 493 women who were randomized to receive either Verzenio plus an aromatase inhibitor – Arimidex (anastrozole) or Femara (letrozole) – or placebo plus an aromatase inhibitor.
Patients treated on a continuous schedule of Verzenio plus an aromatase inhibitor remained free of disease worsening for 28.2 months (2.3 years) compared to 14.8 months (1.2 years) in placebo controls.
Among those treated with Verzenio, 54% re