The US Food and Drug Administration has approved Sanofi and Regeneron Pharmaceuticals' intravenous drug Zaltrap for the treatment of metastatic colorectal cancer.
The approval follows an accelerated review of the drug and a Phase III trial which compared chemotherapy regimen Folfiri in combination with either Zaltrap or a placebo in 1226 patients whose cancer failed to respond to treatment with an oxaliplatin-containing regimen.
Results showed that patients taking Zaltrap with Folfiri increased their median survival from 12.06 months to 13.50 months and progression-free survival from 4.67 months to 6.9 months.
Investigator on the clinical trial and clinical professor of medicine and medical oncology at Jefferson Medical College Edith Mitchell said, "The approval of Zaltrap in combination with a Folfiri chemotherapy regimen offers another treatment option and is welcome news for metastatic colorectal patients and their physicians."
Regeneron chief scientific officer George D Yancopoulos added, "The approval of the novel angiogenesis inhibitor Zaltrap provides a new option to address the unmet medical need in this patient population.
"However, there continues to be a need to develop new cancer therapies. Regeneron and Sanofi continue to devote resources to finding novel investigational treatments and combinations."