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Tuesday, April 22, 2014

FDA Approves Cyramza for Stomach Cancer


The U.S. Food and Drug Administration has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer is unresectable or metastatic after being treated with a fluoropyrimidine- or platinum-containing therapy.


“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release.


The drug’s approval was based on a clinical trial of 355 patients with unresectable or metastatic stomach or gastroesophageal junction cancer who received Cyramza or a placebo. Median overall survival for patients receiving Cyramza was 5.2 months compared with 3.8 months for patients receiving the placebo (OT 5/10/13 issue). And results from a second clinical trial evaluated the efficacy of Cyramza plus paclitaxel versus paclitaxel alone, which showed an increase in overall survival for the patients also receiving Cyramza (OT 2/25/14 issue).


Common side effects reported for the patients receiving Cyramza were diarrhea and high blood pressure.


The drug was reviewed under the agency’s priority review program, which provides for an expedited review of drugs that have the potential (at the time the application was submitted) to be a significant improvement in safety or effectiveness in the treatment of a serious condition (OT 11/25/13 issue). Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.


According to the National Cancer Institute estimates, 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease this year.


Cyramza is marketed by Eli Lilly.