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Lilly's ramucirumab meets in NSCLC trial

February 20, 2014 1:52 AM UTC

Eli Lilly and Co. (NYSE:LLY) said IV ramucirumab ( LY3009806) plus docetaxel met the primary endpoint of improving overall survival (OS) vs. placebo plus docetaxel in the Phase III REVEL trial to treat advanced non-small cell lung cancer (NSCLC). Ramucirumab plus docetaxel also met the secondary endpoint of improving progression-free survival (PFS) vs. placebo plus docetaxel. The double-blind, international trial enrolled more than 1,200 squamous and non-squamous NSCLC patients with disease progression after platinum-based chemotherapy. Lilly said it plans to begin submitting regulatory applications for ramucirumab in NSCLC this year, including an application to FDA in 2H14.

A BLA for ramucirumab as monotherapy for second-line gastric cancer is already under Priority Review. The pharma said it expects a decision from FDA in 2Q14, but is not disclosing a specific PDUFA date. The human IgG1 mAb VEGFR-2 antagonist is also under review in Europe for the indication. This year, Lilly plans to submit regulatory applications for ramucirumab as second-line therapy for gastric cancer in combination with paclitaxel. ...