Bayer files NDA for regorafenib for the treatment of GIST
The US subsidiary of Germany’s Bayer (BAYB: DE) has submitted a New Drug Application to the US Food and Drug Administration for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.
Regorafenib is a Bayer compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals (Nasdaq: ONXX) – with which it has developed Nexavar (sorafenib) - under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will jointly promote regorafenib in the USA (The Pharma Letter October 13, 2011). Regorafenib is currently being investigated in clinical trials for its potential to treat patients with various tumor types.
Priority review
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