FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma


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The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Ramucirumab was approved in April 2014 as a single agent for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy. The combination of ramucirumab with paclitaxel was approved earlier this month.

Improved Overall Survival

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 gastroesophageal junction adenocarcinoma. Patients were randomly assigned to receive either ramucirumab at 8 mg/kg every 2 weeks in combination with paclitaxel at 80 mg/m2 once a week for 3 weeks of every 28-day cycle (n = 330) or matching placebo plus paclitaxel (n = 335).

A statistically significant prolongation of overall survival was demonstrated (hazard ratio [HR] = 0.81, 95% confidence interval [CI] = 0.68–0.96, P = .017). Median overall survival was 9.6 and 7.4 months in the ramucirumab-plus-paclitaxel arm and placebo-plus-paclitaxel arm, respectively. Progression-free survival was also significantly longer for patients receiving ramucirumab plus paclitaxel (HR = 0.64, 95% CI = 0.54–0.75, P < .001).

Safety and Toxicity

Safety data were evaluated in 656 patients who received at least one dose of study drug. The most frequently reported adverse reactions with ramucirumab plus paclitaxel (incidence ≥ 30%) were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. The most common serious adverse reactions with ramucirumab plus paclitaxel were neutropenia and febrile neutropenia (3.7% and 2.4%, respectively).

The recommended dose and schedule for ramucirumab in combination with paclitaxel for advanced gastric or gastroesophageal junction adenocarcinoma are ramucirumab at 8 mg/kg intravenously administered every 2 weeks and paclitaxel at 80 mg/m2 intravenously once a week for 3 weeks of every 28-day cycle. Treatment should continue until disease progression or unacceptable toxicity. ■



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