Ramucirumab First FDA-Approved Drug for Advanced Stomach Cancer after Chemotherapy

June 2014, Vol 5, No 5 - FDA Approvals, News & Updates


The US Food and Drug Administration (FDA) approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, which mostly affects older adults. Ramucirumab is an angiogenesis inhibitor that blocks the blood supply to tumors and is intended to be used in patients with unresectable cancer or with metastatic stomach cancer after receiving chemotherapy with a fluoropyrimidine- or a platinum-containing agent. This is the first FDA-approved therapy for patients with stomach cancer who have already received chemotherapy.

“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 a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Ramucirumab was approved under the FDA’s priority review program, and was also granted an orphan drug status, because it is intended to treat rare conditions.

The safety and efficacy of ramucirumab were demonstrated in a clinical trial of 355 patients with unresectable or metastatic stomach or gastroesophageal junction cancer. Patients were randomized to ramucirumab (66%) or to placebo (34%). The main end point was overall survival (OS). The median OS was 5.2 months with ramuciru­mab compared with 3.8 months with placebo (P <.001). Ramucirumab also improved patients’ progression-free survival compared with placebo. A second trial comparing ramucirumab plus paclitaxel versus paclitaxel alone also showed an OS improvement with the addition of ramucirumab.

Common adverse events reported with ramucirumab in clinical trials include diarrhea and high blood pressure. The recommended dose of ramucirumab is 8 mg/kg every 2 weeks, administered over 60 minutes until disease progression or unacceptable toxicity. (April 21, 2014)