Bayer’s Stivarga Cleared in the EU
The European Commission recently approved Bayer ’s ( BAYRY ) Stivarga (regorafenib) for the treatment of adults suffering from metastatic colorectal cancer (mCRC) whose disease has progressed even after treatment with standard drugs. The EU approval of Stivarga did not come as a surprise as, in Jun 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on the approval of Stivarga in the mCRC indication. The European approval of Stivarga was based on positive results from Bayer’s phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) study […]