FDA Approves Cyramza (ramucirumab) for Stomach Cancer

The US Food and Drug Administration (FDA) has approved Cyramza (ramucirumab) to treat advanced stomach cancer and gastroesophageal junction adenocarcinoma, a type of cancer located where the stomach connects to the esophagus. Patients in a clinical trial who took the drug lived on average 1.4 months longer than patients who did not take it.

Cyramza is given through a vein every 2 weeks. It’s for people whose cancer can’t be removed through surgery or has spread after treatment with other drugs. A targeted therapy, it works by blocking the growth of new blood vessels that help cancer cells grow and spread. Targeted therapies are often able to attack cancer cells while doing less damage to normal cells and causing less severe side effects than standard chemotherapy drugs. This is the first targeted therapy approved to specifically treat stomach cancer.

The FDA evaluated Cyramza under its priority review program that can speed up the approval process for drugs that have the potential to significantly improve treatment of a serious condition.

The FDA based its approval on a clinical trial of 355 patients who had previously had chemotherapy, and whose stomach or gastroesophageal junction cancer had spread and could not be removed through surgery. Two-thirds of the patients received Cyramza and one-third received a placebo (fake drug). Those taking Cyramza lived an average 5.2 months and those taking the placebo lived an average 3.8 months. Those taking Cyramza also lived longer before their cancer got worse.

The most common side effects experienced by trial participants who took the drug included diarrhea, high blood pressure, and headache. This drug can have more serious side effects, too, like bleeding and blood clots.

Cyramza is marketed by Eli Lilly.

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