FDA News

FDA grants priority review to abemaciclib for advanced breast cancer

The FDA granted priority review to abemaciclib for the treatment of two subsets of patients with advanced hormone receptor–positive, HER-2–negative breast cancer, according to the agent’s manufacturer.

The designation applies to use of abemaciclib (LY2835219, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor — as monotherapy for patients who received prior endocrine therapy and chemotherapy for metastatic disease, as well as its use in combination with fulvestrant for women whose disease progressed after endocrine therapy.

“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,” Levi A. Garraway, MD, PhD, senior vice president of global development and medical affairs for Lilly Oncology, said in a company-issued press release. “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.”

The FDA previously granted breakthrough designation to abemaciclib. The agency is expected to make a decision about abemaciclib approval in the first quarter of 2018, according to the press release.

The FDA granted priority review to abemaciclib for the treatment of two subsets of patients with advanced hormone receptor–positive, HER-2–negative breast cancer, according to the agent’s manufacturer.

The designation applies to use of abemaciclib (LY2835219, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor — as monotherapy for patients who received prior endocrine therapy and chemotherapy for metastatic disease, as well as its use in combination with fulvestrant for women whose disease progressed after endocrine therapy.

“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,” Levi A. Garraway, MD, PhD, senior vice president of global development and medical affairs for Lilly Oncology, said in a company-issued press release. “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.”

The FDA previously granted breakthrough designation to abemaciclib. The agency is expected to make a decision about abemaciclib approval in the first quarter of 2018, according to the press release.