New Gastric Cancer Drug Gets FDA Approval
Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab) 10mg/mL injection, for the treatment of patients with advanced or metastatic, gastric cancer or gastro-esophageal junction (GEJ) adenocarcinoma, with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Cyramza, the first FDA-approved treatment for patients in this setting, is a human vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically inhibits the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D by binding to VEGF Receptor 2.
The approval was based on the REGARD trial, a multicenter, randomized, placebo-controlled, double-blind clinical trial of 355 patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy. This was the first Phase 3 trial to demonstrate improvement in overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy.
Participants that received Cyramza 8mg/kg by infusion every two weeks plus best supportive care (BSC) vs. those that received placebo plus BSC, ddemonstrated an increased median overall survival by 37% (median overall survival of 5.2 months [95% confidence interval (CI) 4.4, 5.7] vs. 3.8 months [95% CI 2.8, 4.7] for placebo, P=0.047, hazard ratio 0.78 [95% CI 0.60, 0.998]). Additionally, Cyramza significantly improved progression-free survival, demonstrating a 62% increase in median progression-free survival (2.1 months [95% CI 1.5, 2.7] vs. 1.3 months [95% CI 1.3, 1.4] for placebo, P<0.001, hazard ratio 0.48 [95% CI 0.38, 0.62]).
Cyramza will be available in 100mg/10mL and 500mg/50mL strengths in single-dose vials.
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