FDA approves Cyramza for Gastric Cancer - Eli Lilly

The FDA has approved Cyramza (ramucirumab), from Eli Lilly, as a single-agent treatment for patients with advanced or metastatic Gastric Cancer or gastroesophageal junction (GEJ) Adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this approval, Cyramza becomes the first FDA-approved treatment for patients in this setting.

Approval is based on results of REGARD, a multicenter, randomized, placebo-controlled, double-blind trial which demonstrated that Cyramza plus best supportive care, as compared to placebo plus BSC, increased the median overall survival of patients with advanced gastric cancer by 37 percent (median overall survival of 5.2 months vs. 3.8 months for placebo. It is the first Phase III trial to show improved overall survival and progression-free survival with a biologic agent in advanced Gastric Cancer after prior chemotherapy.