Lilly Breast Cancer Treatment Moves Forward

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INDIANAPOLIS -

Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says the U.S. Food and Drug Administration has accepted the New Drug Application for a potential breast cancer treatment. The application for abemaciclib also received a Priority Review designation, which aims to expedite the approval process by regulators.

Lilly says the NDA includes submission of the potential treatment of advanced breast cancer both on its own and in combination with another drug known as fulvestrant. With the Priority Review designation, the FDA could give is approval or rejection of the drug within eight months instead of the standard 12.

"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, senior vice president of global development and medical affairs with 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."

Lilly says it expects the FDA to make a ruling on the treatment in first quarter 2018. The company says it also intends to submit the treatment to European regulators in third quarter 2017 and to Japanese regulators before the end of this year.

Last week, Lilly announced it had received approval from Japanese regulators for its once-daily treatment of rheumatoid arthritis.

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