Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its New Drug Application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and given the NDA a Priority Review designation.
The NDA includes the company’s submission of abemaciclib for two indications: abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.
“We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy [with fulvestrant] for patients with advanced breast cancer,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. “Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden. We look forward to working with the FDA and bringing this important potential treatment option to patients as soon as possible.”
In 2015, the FDA granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company’s Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. A drug that receives Breakthrough Therapy Designation may be eligible for Priority Review, which aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment. With Priority Review of a new drug, the FDA’s goal is to take action within eight months of receiving an application, compared with the standard review timeframe of 12 months. Lilly is working closely with the FDA and anticipates agency action on this application in the first quarter of 2018.
In addition, Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of 2017.