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FDA grants priority review for ramucirumab as gastric cancer treatment
The FDA granted priority review status to ramucirumab as a single-agent treatment for advanced gastric cancer in patients with disease progression after initial chemotherapy, according to the drug’s manufacturer.
Designed to directly inhibit angiogenesis, ramucirumab (IMC-1121B, Eli Lilly and Company) is a human, receptor-targeted antibody that specifically blocks the VEGF receptor-2 and inhibits signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Priority review status was granted based on data from the REGARD trial, a global, randomized, double blind phase 3 study 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.
In addition, a registration dossier is also under regulatory review by the European Medicines Agency for a marketing authorization application.
Richard Gaynor
“We are very pleased that the FDA has granted priority review to ramucirumab in advanced gastric cancer, as patients with this difficult-to-treat disease typically have a poor prognosis and limited treatment options,” Richard Gaynor, MD, vice president of product development and medical affairs for Lilly Oncology, said in a press release. “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.”
Lilly also studied ramucirumab combined with paclitaxel for the treatment of advanced gastric cancer in its phase 3 RAINBOW trial. The combination-therapy ramucirumab data from this trial will provide the basis for separate regulatory applications.
Additionally, the manufacturer expects results from three additional phase 3 trials of ramucirumab — in colorectal, hepatocellular and lung cancer — in 2014.