NDA Submitted for Regorafenib for Metastatic Colorectal Cancer

Onyx and Bayer HealthCare have submitted a New Drug Application (NDA) to the FDA seeking approval for regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).

The submission is based on the results of the pivotal, global Phase 3 CORRECT trial. The CORRECT study was a multicenter, randomized, double-blind, placebo-controlled study that enrolled 760 patients with mCRC 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 Patients who had withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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 (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.

Regorafenib is an investigational oral multi-kinase and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

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