Eli Lilly, a global pharmaceutical company headquartered in Indianapolis, announced that the U.S FDA has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.  This designation is based on data from the breast cancer of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in advanced or metastatic breast cancer.  In the U.S each year, nearly 232,000 new cases of invasive breast cancer will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.  Metastatic breast cancer is considered incurable, but is generally treatable.

Lilly’s abemaciclib is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6.  Results from preclinical and early-stage clinical studies support the further evaluation of abemaciclib for the treatment of human cancers – including breast cancer and lung cancer – in which aberrant CDK4 and 6 pathways enhance cancer cell growth.

Lilly has an active clinical development program studying abemaciclib in breast cancer.  Abemaciclib now has entered into Phase III development with two clinical trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer.


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