The FDA ( Food and Drug Administration ) 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.
Priority Review status for a biologics license application, or BLA, means that the FDA's goal is to take action within eight months of a completed filing. 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 ( including adenocarcinomas of the gastro-esophageal junction ) following progression after initial chemotherapy.
Ramucirumab is also studied in combination with Paclitaxel for the treatment of advanced gastric cancer in phase III RAINBOW trial. The combination-therapy Ramucirumab data from that trial will be the basis for separate regulatory applications.
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor ( VEGF ) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors. ( Xagena )
Source: Lilly, 2013