FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Eli Lilly Receives Third Approval for Breast Cancer Treatment Verzenio

March 5, 2018
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Eli Lilly’s Verzenio (abemaciclib) received FDA approval for a third indication — the combined use with an aromatase inhibitor as an initial endocrine-based therapy to treat postmenopausal women with HR+, HER2- advanced or metastatic breast cancer.

The drug received its initial approval in September, making it the first cyclin-dependent kinase 4 & 6 inhibitor approved for solo and combined use in treating metastatic breast cancer.

The expanded approval was supported by the efficacy and safety results of the MONARCH 3 clinical trial.

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