The approval makes CYRAMZA, the first FDA-approved treatment for patients with metastatic gastric cancer.
Lilly Oncology senior vice president of product development and medical affairs Richard Gaynor said the company is committed to delivering new medicines that extend the lives of people with cancer.
"Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved CYRAMZA for these patients," Gaynor said.
"This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."
The approval of CYRAMZA (ramucirumab injection 10mg/mL solution) is based on a multicenter, randomized, placebo-controlled, double-blind trial called REGARD.
The Phase III trial was carried out in patients with locally advanced or metastatic gastric cancer including GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy
The trial is designed to show improved overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy.
Results showed that CYRAMZA (8 mg/kg by infusion every two weeks) plus best supportive care (BSC), as compared to placebo plus BSC, increased the median overall survival of patients with advanced gastric cancer by 37%.
According to the company, CYRAMZA should be discontinued in patients who experience severe bleeding.
CYRAMZA is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.
Image: FDA approval of CYRAMZA (ramucirumab injection 10mg/mL solution) is based on a Phase III trial called REGARD carried out in patients with locally advanced or metastatic gastric cancer. Photo: courtesy of Baitong333/ freedigitalphotos.net