FDA Approves Ramucirumab for Stomach Cancer


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The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is a recombinant monoclonal antibody of the IgG1 class that binds to the vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks the activation of the receptor.

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

Improved Overall Survival

The approval was based on the demonstration of improved overall survival in the REGARD trial, a multinational, randomized (2:1), double-blind, multicenter investigation. The trial evaluated ramucirumab’s safety and efficacy in 355 participants with previously treated advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Two-thirds of trial participants received ramucirumab plus best supportive care while the remaining participants received a placebo plus best supportive care.

Results showed patients treated with ramucirumab experienced a median overall survival of 5.2 months compared to 3.8 months in patients receiving placebo (hazard ratio [HR] = 0.78, 95% confidence interval [CI] = 0.60–0.998, P = .047 on stratified log-rank test). Median progression-free survival was also longer in the ramucirumab arm compared to placebo (HR = 0.48, 95% CI = 0.38–0.62, P < .001 on stratified
log-rank test).

Results from a second clinical trial that evaluated the efficacy of ramucirumab plus paclitaxel vs paclitaxel alone also showed an improvement in overall survival.

Safety

The most common adverse events (all grades) observed in ramucirumab-treated patents were hypertension and diarrhea. Grade 3 to 4 adverse reactions reported at a higher incidence in the ramucirumab arm included hypertension and hyponatremia. The most common serious adverse events with ramucirumab were intestinal obstruction and anemia.

The FDA reviewed ramucirumab under its priority review program, which provides an expedited review for drugs that have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. The agent was also granted orphan product designation because it is intended to treat a rare disease or condition.

Ramucirumab is marketed by Eli Lilly. ■



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