Verzenio Gains Expanded Breast Cancer Indication

The approval of Verzenio as initial therapy in combination with an aromatase inhibitor is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial.

Eli Lilly announced that the Food and Drug Administration (FDA) has approved 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 2-negative (HER2-) advanced or metastatic breast cancer.

Verzenio, a cyclin-dependent kinase (CDK) 4 & 6 inhibitor, was initially approved in September 2017 in combination with fulvestrant for the treatment of women with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

The latest approval was supported by data from the Phase 3, randomized, double-blind, placebo-controlled MONARCH 3 trial which evaluated Verzenio in combination with an AI (anastrozole or letrozole) in 493 postmenopausal women with HR+, HER2- advanced breast cancer who had no prior systemic treatment for advanced disease. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall response rate (ORR), duration of response (DoR), overall survival and safety.

Verzenio 150mg twice daily given continuously with an AI showed a greater 28-month median PFS in patients who received initial endocrine-based therapy for metastatic disease vs placebo with an AI (28.2 months vs. 14.8 months; hazard ratio [HR] 0.54, 95% CI: 0.418–0.698; P<0.0001).

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An ORR of 55.4% was seen among patients who received Verzenio + AI, with 52.1% of patients achieving a partial response (defined as ≥30% reduction in target lesions) and 3.4% of patients acheiving a complete response. ORR among patients who received placebo + AI was 40.2% with all the patients being partial responders. The median DoR was 27.4 months for patients in the Verzenio + AI group vs 17.5 months in the placebo + AI group. 

Verzenio is available as 50mg, 100mg, 150mg, and 200mg strength tablets. 

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