FDA Approves Cyramza for Advanced Stomach Cancer or Gastroesophageal Junction Adenocarcinoma

The FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer and gastroesophageal junction adenocarcinoma. The injectable drug, an angiogenesis inhibitor marketed by Eli Lilly and Company, is the first FDA-approved treatment for the disease following chemotherapy.

Ramucirumab was reviewed under the priority review program and was granted orphan product designation for drugs intended to treat rare diseases or conditions.

In a news release, the FDA cited statistics from the National Cancer Institute that estimates 22,220 people in the United States will be diagnosed with stomach cancer this year and 10,990 people will die from the disease.

The safety and efficacy of ramucirumab was evaluated in a multicenter, randomized, placebo-controlled, double-blind study. Patients who received 8 mg/kg of ramucirumab every 2 weeks plus best supportive care had a median overall survival of 5.2 months compared with 3.8 months for patients who received placebo (P=.047). The median progression-free survival was 2.1 months in the ramucirumab group and 1.3 months in the placebo group (P<.001).

Common side effects associated with ramucirumab included diarrhea and high blood pressure.

A news release from Eli Lilly and Company noted that ramucirumab's labeling contains a boxed warning regarding an increased risk of hemorrhage, including severe and sometimes fatal events. Patients who experience severe bleeding while taking ramucirumab should discontinue the drug, according to the company.