Eli Lilly's Stomach Cancer Drug Cyramza Receives FDA Approval

The U.S. Food and Drug Administration (FDA) granted approval to Eli Lilly’s Cyramza (ramucirumab) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

Cyramza is an angiogenesis inhibitor that works to block blood supply to tumors. The drug is intended for patients with unresectable or metastatic cancer after undergoing treatment 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. Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth,” said Richard Pazdur, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Stomach cancer originates in the tissues lining the stomach. The disease affects mostly older adults. An estimated 22,220 patients in the U.S. will be diagnosed with stomach cancer this year, according to the National Cancer Institute. Of these, about 10,990 will die from the disease.

Eli Lilly said Cyramza is the first FDA-approved treatment for advanced gastric cancer after prior chemotherapy. “Lilly Oncology is committed to delivering innovative medicines that extend the lives of people with cancer. Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved CYRAMZA for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor,” said Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology.

The FDA approval was based on positive results from two clinical trials demonstrating Cyramza’s efficacy and superiority in combination with another cancer drug paclitaxel over paclitaxel alone.

Cyramza was reviewed under its priority review program. The FDA also granted orphan drug designation to Cyramza as it was intended to treat a rare disease or condition.