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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly and Company’s Abemaciclib for treatment of patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.
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The designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, which studied the efficacy and safety of abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in women with advanced or metastatic breast cancer.
During the trial, also called JPBA, patients received a median of seven prior systemic treatments.
Lilly Oncology product development and medical affairs senior vice president Richard Gaynor said: "If caught before it spreads, patients can survive breast cancer.
"However, for the nearly 10 percent of patients who are initially diagnosed at stage IV,1 and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease,1 there remains an urgent need for effective therapy options.
"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."
Breakthrough Therapy Designation is designed to accelerate the development and review of drugs that are intended to treat a serious condition.
The company is currently conducting multiple trials to study abemaciclib in breast cancer, which includes MONARCH 1, 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.
Additionally, the drug is also being evaluated in two Phase III clinical trials, including MONARCH 2 that evaluates the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer.
MONARCH 3 trial seeks to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.