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New Cancer Drug Ramucirumab (Eli Lilly & Co.) Prioritized by FDA

Posted in Drug Studies

Headquartered in Indianapolis, Indiana, Eli Lilly and Company is a pharmaceutical company with offices all over the world.  Recently, the company developed a single-agent treatment for gastric cancer; a drug called Ramucirumab.  Ramucirumab is used if cancer continues to progress after initial chemotherapy.  And according to a report published 10-24-2013 by PharmaceuticalBusinessReview.com, the company recently received priority review status from the US Food and Drug Administration, in attempt to expedite the process of getting the drug approved for use by the public.

Cancer has the unique ability to manipulate the body’s healthy cells and make them work in favor of the cancer: new blood vessels will grow and adhere to the cancerous tumor, supplying it with all the nutritious blood it needs to grow and spread to other parts of the body.  Ramucirumab was designed to stop the signal from the cancer to form these blood vessels to the tumor.

A randomized, double blind phase III trial called REGARD was used for data that granted the priority review status for a biologics license application. This double-blind clinical trial tested Ramucirumab (plus the highest quality supportive care) vs. a placebo medicine (with the highest quality supportive care) for patients who had disease progression after chemotherapy.

The oncology vice president of product development and medical affairs of Eli Lilly and Company claims that Ramucirumab will the first type of FDA-approved therapy for this setting.  While all types of cancer are serious, stomach cancer is the second most common cancer world-wide and is often fatal.  Currently, Eli Lilly and Company is hoping for good results from three other Phase III trials of Ramucirumab in colon, hepatocellular, and lung cancer set to take place in 2014.  I too hope for the success of this drug.