The US Food and Drug Administration today announced that is has approved Cyramza (ramucirumab) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
Stomach cancer is a disease that largely affects older adults, and according to the National Cancer Institute, as many as 22,220 Americans will be diagnosed with stomach cancer each year and the disease will claim as many as 10,990 lives.
Cyramza is an angiogenesis inhibitor. This means it blocks the development of blood vessels that create a blood supply to tumors. Cyramza is intended for patients with unresectable or metastatic disease despite treatment involving a fluoropyrimidine- or platinum-containing therapy.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement:
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. Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.
This drug's safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo.
The trial's primary endpoint was overall survival.
Results demonstrated a median overall survival of 5.2 months for patients receiving Cyramza, 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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