Bayer seeks to expand Stivarga's EU label

Less than a week after the European Commission approved Stivarga regorafenib to treat metastatic colorectal cancer (mCRC), Bayer AG (Xetra:BAYN) submitted an MAA to EMA seeking to expand the drug's label to include treatment of gastrointestinal stromal tumors (GIST) in patients who have been previously treated with two tyrosine kinase inhibitors (TKIs). The EC approved Stivarga last Friday to treat mCRC. The dual acting signal transduction (DAST) inhibitor is already approved in the U.S. to treat mCRC and locally advanced, unresectable or metastatic GIST, and in Japan to treat unresectable, advanced or recurrent colorectal cancer. ...