Friday, November 16, 2012

ZALTRAP® (aflibercept) Receives CHMP Positive Opinion in the European Union for Previously Treated Metastatic Colorectal Cancer

Sanofi and Regeneron Pharmaceuticals, Inc.today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended the granting of marketing authorization for ZALTRAP® (aflibercept) 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.

The positive recommendation is based on the results from the pivotal Phase 3trial - VELOUR
The VELOUR trial was a Phase III multinational, randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAP or placebo in the treatment of patients with mCRC. The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-containing regimen. Twenty-eight percent of patients in the study received prior bevacizumab therapy. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, overall response rate, and safety

The VELOUR trial showed that in patients previously treated with an oxaliplatin-containing regimen,
adding ZALTRAP to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months (HR=0.817 [95% CI 0.714 to 0.935]; p=0.0032, an 18 percent relative risk reduction. A significant improvement in progression-free survival from 4.67 months to 6.90 months (HR=0.758 [95% CI 0.661 to 0.869]; p=0.00007), a 24 percent relative risk reduction, was also observed. The overall response rate in the ZALTRAP plus FOLFIRI arm was 19.8% vs. 11.1% for FOLFIRI (p=0.0001)

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