Eli Lilly and Company (LLY)

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FDA Grants Lilly's Ramucirumab Priority Review For Advanced Gastric Cancer

By RTT News, October 23, 2013, 07:00:00 AM EDT

Eli Lilly and Co. ( LLY ) reported that the U.S. Food and Drug Administration or FDA 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.

According to 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."

The Priority Review status for a biologics license application, or BLA, indicates that the FDA's aim is to take action within 8 months of a completed filing. Hence, Lilly expects agency action on this application in the second quarter of 2014. The priority designation aims at expediting the review of applications for drugs that, if approved, would represent a significant advance in treatment.

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

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