The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.
Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth factor receptor 2 and inhibits downstream signaling involved in angiogenesis.
The biologics license application for ramucirumab was based on data from REGARD, a global, randomized, double-blind phase III study of ramucirumab plus best supportive care vs placebo plus best supportive care as a treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastroesophageal junction) following progression after initial chemotherapy. ■
