New Gastric Cancer Drug Gets FDA Approval

New Gastric Cancer Drug Gets FDA Approval
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.

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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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