Bayer files for EU approval of regorafenib for GIST

5 September 2013

German pharma major Bayer (BAYN: DE) said this morning (September 5) that it has submitted an application for marketing authorization to the European Medicines Agency for the oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST) who have been previously treated with two tyrosine kinase inhibitors.

The EMA filing follows the European Union approval last month of regorafenib (Stivarga), which is partnered with USA-based Onyx Pharmaceuticals (Nasdaq: ONXX), for use in metastatic colorectal cancer (The Pharma Letter August 30).

“The submission of regorafenib to EMA is an exciting advance because it means patients with GIST will have a potential new treatment option to help manage an aggressive disease”, said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development.

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