Advanced stomach cancer drug approved by the FDA
21 Apr 2014
The FDA has approved ramucirumab (an angiogenesis inhibitor, trade name: "Cyramza") for treatment of advanced gastric cancer or gastroesophageal adenocarcinoma. The approval encompasses patients with unresectable or metastatic disease.
A fully human monoclonal antibody, ramucirumab inhibits vascular endothelial growth factor receptor-2 (VEGFR2), which mediates VEGF's downstream effects on tumor angiogenesis.
Slower disease progression in clinical trial
The approval was based primarily on data from a randomized clinical trial showing that patients treated with ramucirumab had slower disease progression and lived about 1.5 months longer than did patients in a placebo group.
"Although 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," Richard Pazdur, MD, of the FDA Center for Drug Evaluation and Research, said in a statement. "Cyramza is a new treatment option that has demonstrated an ability to extend patients' lives and slow tumor growth."
The pivotal randomized trial involved 355 patients with unresectable or metastatic cancer of the stomach or GEJ. Patients were randomized 2:1 to ramucirumab or placebo, and the trial had a primary endpoint of overall survival (OS).
Longer overall survival shown
Results showed that patients treated with ramucirumab had a median OS of 5.2 months versus 3.8 months in the placebo group. The 6-month survival was 42% with ramucirumab and 32% with placebo, and 12-month survival was 18% versus 12% in favor of ramucirumab. Treatment with ramucirumab also was associated with improvement in median progression-free survival.
Earlier this year, data from another randomized trial showed that the addition of ramucirumab to paclitaxel led to a 2-month improvement in OS in patients with advanced and metastatic gastric or GEJ cancer.
Source: MedPage Today: http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/45356