FDA Grants Priority Review to Ramucirumab as Single-Agent Treatment for Advanced Gastric Cancer
Final approval decision expected in second quarter 2014 (October 23)
The FDA has assigned priority review status to the regulatory submission for ramucirumab (IMC-1121B, Eli Lilly) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.
Priority review status for a biologics license application (BLA) means that the FDA’s goal is to take action within 8 months of a completed filing. Therefore, agency action on the new application is expected in the second quarter of 2014.
The BLA for ramucirumab was based on positive data from the REGARD trial, a global, randomized, double-blind phase III study of ramucirumab plus best supportive care compared with placebo plus best supportive care as a treatment for patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy.
Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2, thereby inhibiting the downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
The drug is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple types of cancer. Beyond gastric cancer, results from three phase III trials — one each in colorectal, hepatocellular, and lung cancer — are expected in 2014.
Source: Eli Lilly; October 23, 2013.