Lilly’s Ramucirumab Gets Priority Review

Eli Lilly and Co.’s BLA for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy, has been assigned Priority Review by the FDA. Lilly anticipates agency action on this application in 2Q14. The priority designation aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment.

This BLA for ramucirumab was based on data from REGARD, a global, randomized, double-blind Phase III study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer. A registration dossier is also under review by the EMA.