Bayer HealthCare,, the US-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).

Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumour types. Regorafenib is an investigational agent and is not approved by the FDA, EMA or other health authorities.

Regorafenib is one of several cancer compounds in Bayer’s development pipeline. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.

“Bayer HealthCare is pleased to have reached this development milestone in regards to filing with the FDA,” said Pamela A. Cyrus, M.D., vice president and head of US Medical Affairs, Bayer HealthCare Pharmaceuticals, “This is an important step toward our goal of bringing new treatment options to people living with cancer.”

The submission is based on the results of a 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 Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and will be presented at the upcoming ASCO annual meeting in Chicago, IL (USA) in early June 2012.

Bayer has also submitted an application for European marketing authorization for regorafenib for the treatment of patients with mCRC.

The CORRECT study was an international, multi-centre, randomized, double-blind, placebo controlled phase III 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Patients who had withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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 160 mg of regorafenib (or matching placebo)
once daily for three weeks on / one week off plus BSC. The study was conducted in North America, Europe, China, Japan and Australia.