Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC).
The company has even filed an application with European marketing authorization for regorafenib for the treatment of patients with mCRC.
The submission is based on the results of a pivotal, global Phase III Colorectal cancer treated with regorafenib or placebo after failure of standard therapy trial.
The multicenter, randomized, double-blind, placebo-controlled has enrolled 760 patients with mCRC whose disease had progressed during or within three months following last administration of approved standard therapies.
Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.
Treatment cycles consisted of 160mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC.