New drug application filed with FDA for BAY 73-4506 (Bayer HealthCare) for metastatic Colorectal Cancer

Bayer HealthCare has submitted a New Drug Application FDA seeking approval for the oral multi-kinase inhibitor BAY 73-4506 (regorafenib) for the treatment of patients with metastatic Colorectal Cancer (mCRC). The submission is based on the results of a pivotal, global Phase III CORRECT trial which showed an improvement of overall survival of 29% and placebo patients were transferred to regorafenib therapy. Bayer reports that patients on regorafenib therapy lived 6.4 months longer compared with 5 months for those on placebo. Bayer HealthCare has also filed regorafenib at the EU.