The decision was based upon evidence from Phase III trial data which showed Zaltrap to be the first and only agent to statistically significantly improve survival in combination with FOLFIRI chemotherapy after an oxaliplatin regimen.
Colorectal cancer is the most common cancer in both men and women in Europe and is the second leading cause of cancer death.
The treatment is marketed by Sanofi and Regeneron Pharmaceuticals.
Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology, thanked “physicians, patients and their families” for their efforts in getting the injection approved.
“We are thrilled to provide a new therapy that further extends the lives of patients with metastatic colorectal cancer and look forward to working with European health authorities to ensure patients have access to Zaltrap,” he said.
Dr George Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added that the treatment “provides a new option to address the unmet medical need” across Europe.
Zaltrap received approval by the US FDA back in August 2012 following a priority review by the agency. It is also under review with other health regulators across the world.