INDIANAPOLIS – A new therapy has received fast-track approval for treatment of advanced stomach cancer.
The Food and Drug Administration has approved Cyramza (ramucirumab) to treat patients with gastroesophageal junction adenocarcinoma. Cyramza, marketed by Eli Lilly of Indianapolis, is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients with unresectable cancer or metastatic cancer 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,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”
Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Results indicated that participants treated with Cyramza had a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of Cyramza plus paclitaxel vs. paclitaxel alone also showed an improvement in overall survival.
Diarrhea and high blood pressure were common side effects experienced by Cyramza-treated participants during clinical testing.
The FDA reviewed Cyramza under its priority review program, which provides an expedited review for 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. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.