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Breakthrough Designation for Abemaciclib in Breast Cancer

Eli Lily’s CDK4 and 6 inhibitor receives breakthrough therapy designation for advanced or metastatic disease

Abemaciclib (Eli Lilly), which is being studied for patients with  refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer, has been granted the FDA’s breakthrough therapy designation. This designation is based on data from the breast cancer cohort expansion of the company’s JPBA phase I trial, which studied the efficacy and safety of abemaciclib in women with metastatic breast cancer.

Breakthrough therapy designation is meant to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

According to Lilly, an ongoing clinical development program is studying abemaciclib in breast cancer. MONARCH 1 is a phase II trial evaluating the use of abemaciclib as monotherapy in women with HR+, human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients 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 cell cycle inhibitor designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both, the results from cell-free enzymatic assays have shown that it was most active against cyclin D1 and CDK 4. Results from preclinical and early-stage clinical studies support the evaluation of abemaciclib for the treatment of human cancers, including breast cancer and lung cancer, in which aberrant CDK 4 and 6 pathways enhance cancer cell growth.

Sources: Lilly, October 8, 2015; BioSpace, October 8, 2015.

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