BioCentury
ARTICLE | Company News

Lilly's Verzenio gets Priority Review for label expansion

October 12, 2017 8:32 PM UTC

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to an NDA for Verzenio abemaciclib as a first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Lilly declined to disclose the PDUFA date.

The NDA is based on interim results from the Phase III MONARCH 3 trial, in which Verzenio plus aromatase inhibitors anastrozole or letrozole significantly improved progression-free survival (PFS) vs. either aromatase inhibitor alone, meeting the study's primary endpoint (see BioCentury Extra, April 24)...