Stomach Cancer: FDA Okays New Drug Cyramza

The U.S. Food and Drug Administration passed  Eli Lilly's drug Cyramza  for treatment of  patients with stomach cancer.

The angiogenesis inhibitor 'Cyramza' has been passed by the federal regulators to treat advanced cancer or gastroesophageal junction adenocarcinoma,  a cancer that occurs in the region where the esophagus joins the stomach.

 The newly approved drug is meant for only those patients whose cancer cannot be surgically removed (unresectable) or has spread to other regions (metastatic) after being treated with fluropyrimidine- or plantinum-containing therapy.

In stomach cancer the cells lining the inner wall of the stomach become cancerous.  This cancer occurs mostly in older adults. The National Cancer Institute statistics reveal that this year nearly 22,220 Americans will be diagnosed with stomach cancer and over 10,990 will die from the disease.

"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, M.D., 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."

 The safety and effectiveness of the drug was evaluated in a clinical trial that included over 355 subjects with unresectable and metastatic stomach or gastroesophageal junction cancer. Two thirds of the subjects were given Cyramza and the others received a placebo.

The researchers observed that those who received Cyramza experienced a delay in tumor growth compared to the placebo group.  In a second trial they evaluated the efficacy of Cyramza plus paclitaxel (a cancer fdrug) versus paclitaxel alone. An improvement was noticed in the patients.

The common side effects reported during the clinical trial were diarrhea and high blood pressure.

The FDA highlighted that the drug is currently under a priority review program. As the drug is used to only treat a rare disease or condition, the FDA has granted it the orphan product designation.