Lilly announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

The designation is based on data from the breast cancer cohort expansion of the Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer who received a median of seven prior systemic treatments

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Abemaciclib is currently being studied in a clinical development program that includes a Phase 2 trial, MONARCH 1, to evaluate its use as monotherapy in women with HR+, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, and two Phase 3 trials: MONARCH 2, to evaluate the combination of abemaciclib and fulvestrant in postmenopausal women with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3, to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

Abemaciclib (LY2835219) is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor.

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