FDA Grants Priority Review to Ramucirumab for Advanced Gastric Cancer
Eli Lilly and Company announced that the FDA has granted Priority Review to the Biologics License Application (BLA) for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits the downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
The submission was based on data from REGARD, a global, randomized, double-blind Phase 3 study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer, including adenocarcinomas of the gastro-esophageal junction following progression after initial chemotherapy.
Ramucirumab has also been studied in combination with paclitaxel for the treatment of advanced gastric cancer in the Phase 3 RAINBOW trial. The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly is also conducting three separate Phase 3 trials of ramucirumab in colorectal, hepatocellular and lung cancer in 2014.For more information call (800) 545-5979 or visit Lilly.com.