The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST).
The drug is specified for people who have been previously treated with two tyrosine kinase inhibitors.
The EMA filing follows the European approval of regorafenib in August 2013 for using it as a therapy for metastatic colorectal cancer (mCRC).
Bayer HealthCare member of the executive committee and head of global development Kemal Malik said, "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."
Regorafenib, sold under the brand name Stivarga, has already been approved as a GIST treatment in the US and Japan.
Stivarga is a compound developed by Bayer that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and the tumor microenvironment.
