On Monday, April 21, the Food and Drug Administration approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or cancer where the esophagus meets the stomach (gastroesophageal junction adenocarcinoma). This approval includes patients with inoperable cancers and those with metastatic disease after treatment with platinum- or fluoropyrimidine-based chemotherapy.
Cyramza is a type of drug known as an angiogenesis inhibitor, which means it blocks the tumor’s blood supply.
This past October, the therapy was given priority review status (meaning the FDA would make a decision within six months) after promising clinical trial results and because it met an unfilled need. This approval makes Cyramza the first approved single-agent treatment for stomach cancer after it has progressed following initial therapy.
The FDA based the approval on results from the REGARD trial, an international, phase 3 study in which 355 previously treated patients with either stomach cancer or gastroesophageal junction adenocarcinoma were randomly assigned to receive either Cyramza or best supportive care. Treatment with Cyramza improved median overall survival by 1.4 months compared with those receiving placebo.
Earlier this year, data from another study pointed to further benefits of Cyramza therapy. The phase 3 RAINBOW trial looked at adding Cyramza to paclitaxel when treating these diseases after prior therapy. The combination extended median overall survival to 9.63 months compared with 7.36 months for patients who received paclitaxel plus placebo. Furthermore, the combination of Cyramza and paclitaxel also prolonged progression-free survival: 4.4 months compared with 2.86 months.
Common side effects of Cyramza include diarrhea and high blood pressure.
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