[Regorafenib approved in Metastatic Colorectal cancer]

Regorafenib, oral multi-kinase inhibitor that targets oncogenesis, tumor angiogenesis and maintenance of the tumor microenvironment, obtained its European approval, August 26, 2013 after favorable review of the European Medecines Agency in the following indication: treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy or are not considered candidates for available therapies and, if KRAS wild type, an anti-EGFR therapy. This decision was based on the efficacy and safety results of an international phase III trial. This study showed an improved overall survival, with régorafénib versus placebo (6.4 months vs 4 months; HR = 0.774, IC à 95%, 0.64 à 0.94; p = 0,005 2). Reported grade 3-4 adverse events with regorafenib were hand-foot syndrome (17%), asthenia (10%), diarrhea (7%), hypertension (7%), rash and desquamation (6%).