Cyramza Approved for Combo Therapy in Advanced Gastric Cancer
FDA has approved ramucirumab for use in combination with paclitaxel for the treatment of gastric cancer.
The Food and Drug Administration (FDA) has approved ramucirumab (Cyramza; Eli Lilly) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Cyramza was initially approved in April 2014 as a single drug for the treatment of advanced gastric or GEJ adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
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The new approval was based on the results from I4T-IE-JVBE, a multicenter, double-blind, placebo-controlled study, that evaluated patients with previously-treated advanced or metastatic gastric or GEJ adenocarcinoma. Patients were randomized to either ramucirumab 8mg/kg every two weeks with paclitaxel (n=330) or placebo with paclitaxel (n=335).
The study showed significant prolongation of overall survival (HR 0.81; 95% CI 0.68, 0.96; P=0.017) in the ramucirumab plus paclitaxel arm (9.6 months) vs. the placebo plus paclitaxel arm (7.4 months). Also, progression-free survival was higher in the ramucirumab plus paclitaxel group (HR 0.64, 95% CI 0.54, 0.75; P<0.001).