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24 May 2012

Bayer Submits Applications for Regorafenib

The submissions are supported by data from the pivotal, global Phase III CORRECT trial.

Bayer HealthCare has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) and a New Drug Application to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).

 

The submissions are supported by data from 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 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.

 

The study ev

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