Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission (EC) has granted marketing authorization in the European Union for ZALTRAP 25mg/ml concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
This decision was based on the efficacy and safety results of the VELOUR Phase 3 trial."ZALTRAP is an important addition to the metastatic colorectal cancer treatment landscape and helps to fill a critical treatment gap," said Eric Van Cutsem, M.D., Ph.D., University Hospitals Leuven, Belgium and lead investigator of the VELOUR study.
ZALTRAP is the first and only agent to demonstrate a survival improvement in a Phase 3 trial in patients previously treated with an oxaliplatin-based regimen who are being treated with FOLFIRI for their metastatic disease.""I would like to thank the physicians, patients, and their families for their support in moving ZALTRAP through the clinical trial process leading to approval in Europe," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology.
"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."In Europe, colorectal cancer is the most common cancer in both men and women and is the second leading cause of cancer death. In 2008, there were 436,000 new cases diagnosed and 212,000 deaths from colorectal cancer.
Commenting on the marketing authorization, George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added: "The European approval of ZALTRAP provides a new option to address the unmet medical need in this patient population. There continues to be a need to develop new cancer therapies and Regeneron and Sanofi are committed to finding novel investigational treatments and combinations."ZALTRAP received approval from the U.S. Food and Drug Administration (FDA) in August 2012 after a Priority Review, and marketing authorization applications for ZALTRAP are under review with other regulatory agencies worldwide.
About the VELOUR Phase 3 Study
The ZALTRAP approval was based on data from the pivotal Phase 3 VELOUR trial, a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAP or placebo in the treatment of patients with mCRC. Â The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-containing regimen. Â Twenty-eight percent of patients in the study received prior bevacizumab therapy. The primary endpoint of the trial was overall survival. Â Secondary endpoints included progression-free survival, overall response rate, and safety.