Photo courtesy Eli Lilly & Co. |
FDA NEWS RELEASE – April 21, 2014 – The FDA announced today approval of Cyramza (ramucirumab) for treatment of advanced cancers of the stomach and esophagus that continue to progress despite treatment with other chemotherapy. The drug developed by Eli Lilly and Company was granted Orphan Drug Designation, and targets a growth factor involved in tumor blood vessel formation needed to sustain tumor growth. The approval was based on a trial of 355 patients with gastric (stomach) cancers including those that start at the junction of the esophagus and the stomach neck. Two-thirds of the patients received standard chemotherapy and Cyramza and the remaining third received standard chemotherapy and placebo.Those in the Cyramza group had a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure.
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