Abemaciclib gets Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Lilly’s abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

Abemaciclib is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6.

Lilly explained that the Breakthrough Therapy designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments.

Lilly has an active clinical development programme for abemaciclib in breast cancer

“If caught before it spreads, patients can survive breast cancer. However, for the nearly 10% of patients who are initially diagnosed at stage IV, and the nearly 30% of patients whose early-stage cancer will re-occur as metastatic disease, there remains an urgent need for effective therapy options,” said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. “We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review.”

Lilly has an active clinical development programme studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (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.