The US Food and Drug Administration (FDA) expanded the indication of ramucirumab (Cyramza, Eli Lilly) to include the treatment of metastatic non-small cell lung cancer (NSCLC).
Ramucirumab is a fully human monoclonal antibody that was developed for the treatment of solid tumors. It is a vascular endothelial growth-factor receptor 2 (VEGFR) antagonist that specifically binds and blocks activation of that receptor.
Earlier this year, the drug was approved for the treatment of gastric cancer, as both a monotherapy and in combination with paclitaxel. This is the third indication that ramucirumab has been approved for in 2014.
The approval is based on findings from the phase 3 REVEL trial, an international study that involved 1253 patients with nonsquamous and squamous cell NSCLC from 26 countries on six continents (Lancet. 2014;384:665-673).
The study compared ramucirumab plus docetaxel with placebo plus docetaxel in NSCLC patients who experienced disease progression after treatment with platinum-based chemotherapy for locally advanced or metastatic disease.
Overall survival was 1.4 months longer with ramucirumab than with placebo.
Median overall survival was better in the ramucirumab group than in the placebo group (10.5 vs 9.1 months; hazard ratio [HR], 0.857; P = .0235), as was median progression-free survival (4.5 vs 3.0 months; HR, 0.762; P < .0001). The overall response rate was also better in the ramucirumab group (23% vs 14%; P < .0001). “The improvement of overall survival and progression-free survival in the ramucirumab-plus-docetaxel arm was also consistent across the majority of subgroups, including histology,” said Maurice Pérol, MD, from the Léon-Bérard Cancer Centre in Lyon, France, who was co-lead investigator of the REVEL study, in a statement. “Overall, these results are very encouraging for those of us who treat lung cancer patients,” he said. Source: Medscape