BioCentury
ARTICLE | Financial News

Lilly submitting ramucirumab BLA

April 25, 2013 12:01 AM UTC

Eli Lilly and Co. (NYSE:LLY) disclosed in its 1Q13 earnings on Wednesday that it received Fast Track designation and began submission of a rolling BLA to FDA for ramucirumab as a monotherapy for second-line gastric cancer. Lilly expects to submit the final module by year end. In October, Lilly reported the human IgG1 mAb VEGFR-2 antagonist met the primary endpoint in the Phase III REGARD trial to treat metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum or fluoropyrimidine-containing combination therapy (see BioCentury Extra, Oct. 15, 2012). ...