PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN), along with Sanofi (SNY), Tuesday said the European Commission has granted marketing authorization for ZALTRAP solution in the European Union.
ZALTRAP solution is used in combination with DNA inhibitors for chemotherapy in adults with metastatic colorectal cancer that is resistant to, or has progressed, after an oxaliplatin-containing regimen.
The approval was based on the efficacy and safety results of the VELOUR Phase 3 trial, a randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAP or placebo in the treatment of patients with metastatic colorectal cancer.
The study 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, an 18 percent relative risk reduction.
A significant improvement in progression-free survival from 4.67 months to 6.90 months, a 24 percent relative risk reduction, was also observed.
The overall response rate in the ZALTRAP plus FOLFIRI arm was 19.8 percent vs. 11.1 percent for FOLFIRI alone.
Meanwhile, the most common adverse reactions, reported at a higher incidence, included leukopenia, diarrhea, neutropenia, proteinuria, fatigue, thrombocytopenia, ALT increased, hypertension, abdominal pain, dysphonia, serum creatinine increased, and headache.
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