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.
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).
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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).
The full prescribing information for Cyramza has been updated accordingly.
For more information call (800) 545-5979 or visit Cyramza.com.