FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer


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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. ■


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