Bayer HealthCare announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the oral multikinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer. The submission is based on the results of the pivotal, global phase III CORRECT (Colorectal Cancer Treated with Regorafenib or Placebo after Failure of Standard Therapy) trial. Results from the study were first presented at the Gastrointestinal Cancers Symposium in January 2012 and were subsequently presented at the ASCO Annual Meeting in Chicago this month.
The CORRECT study was an international, multicenter, randomized, double-blind, placebo-controlled phase III study that enrolled 760 patients with metastatic colorectal cancer whose disease had progressed during or within 3 months following last administration of approved standard therapies. Patients who had withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease were also allowed into the study.
Patients were randomized to receive either regorafenib plus best supportive care or placebo plus best supportive care. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for 3 weeks on/1 week off plus best supportive care.
The study was conducted in North America, Europe, China, Japan, and Australia. ■