Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.
Designed to directly inhibit angiogenesis, ramucirumab is a human, receptor-targeted antibody that blocks the vascular endothelial growth factor (VEGF) receptor-2 and inhibits signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Priority review status for a biologics license application (BLA) was granted based on data secured from the REGARD trial.
REGARD is a global, randomized, double blind Phase III trial of ramucirumab combined with best supportive care vs. placebo combined with best supportive care for patients with advanced gastric cancer who have had disease progression after initial chemotherapy.
Additionally, a registration dossier is also under regulatory review by the European Medicines Agency (EMA) for a marketing authorization application.
Lilly Oncology vice president of product development and medical affairs Richard Gaynor said if approved, ramucirumab will be the first FDA-approved therapy for patients in this setting.
"Overall, stomach cancer is the second leading cause of cancer death globally and remains an area of high unmet need."
The company has also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its Phase III RAINBOW trial and the data from the combination-therapy will be the basis for separate regulatory applications.
Additionally, the company expects top-line results from three additional Phase III trials of ramucirumab in colorectal, hepatocellular and lung cancer in 2014.
