FDA grants Priority Review to Lilly's ramucirumab for treatment of advanced gastric cancer

Oct 23 2013

Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

"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," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "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."

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. Therefore, Lilly anticipates agency action on this application in the second quarter of 2014. 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. A registration dossier is also under regulatory review by the European Medicines Agency (EMA) for a Marketing Authorization Application.

Lilly also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its Phase III RAINBOW trial. The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly expects top-line results from three additional Phase III trials of ramucirumab – one each in colorectal, hepatocellular (liver) and lung cancer – in 2014.

SOURCE Eli Lilly and Company