FDA Reviews 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.

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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.
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