Lilly's abemaciclib gets Priority Review

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to an NDA for abemaciclib (LY2835219) to treat advanced breast cancer. Its PDUFA date is in 1Q18.

Specifically, abemaciclib is under review as monotherapy to treat hormone receptor-positive, HER2-negative advanced breast cancer in patients who had prior endocrine therapy and chemotherapy for metastatic disease; and in combination with Faslodex fulvestrant to treat hormone receptor-positive, HER2-negative advanced breast cancer in women who had disease progression following endocrine therapy. Lilly based the submission on data from the Phase II MONARCH 1 and Phase III MONARCH 2 trials (see BioCentury Extra, March 20)...