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FDA OK's Abemaciclib for First-Line Tx (Reuters)

— Findings based on the MONARCH 3 phase III trial

MedpageToday

The CDK4/6 inhibitor abemaciclib (Verzenio) received an expanded indication by the FDA, the maker Eli Lilly announced yesterday.

reported the breast cancer drug -- originally indicated as use after endocrine therapy following disease progression -- is now approved as initial treatment for postmenopausal women with advanced or metastatic HR positive, HER2-negative breast cancer in combination with an aromatase inhibitor.

Approval was based on findings of the MONARCH 3 late-stage trial, presented at last year's ESMO meeting, which found abemaciclib twice daily plus anastrozole or letrozole significantly increasing progression-free survival compared to placebo plus one aromatase inhibitor.