The drug combination showed a significant improvement of 2.2 months in OS compared to the placebo arm.
On November 5, 2014, the FDA approved ramucirumab (Cyramza, Eli Lilly and Company) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was approved in April, 2014 as a single agent for the treatment of patients with advanced gastric or GEJ adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy.
The approval of ramucirumab in combination with paclitaxel was based on the demonstration of improved overall survival in a multicenter, double-blind, placebo-controlled study (I4T-IE-JVBE) that enrolled 665 patients with previously-treated advanced or metastatic gastric or GEJ adenocarcinoma. Patients were randomized to receive either ramucirumab (8 mg/kg every 2 weeks) in combination with paclitaxel (80 mg/m2 once a week for 3 weeks of every 28-day cycle) (n = 330) or matching placebo plus paclitaxel (n = 335).
Link to the report on the FDA website: http://1.usa.gov/1uAHO1p