Bayer gets Japanese OK for GI stromal tumors drug

20 August 2013

German drug major Bayer (BAYN: DE) has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the marketing of Stivarga (regorafenib) for the treatment of patients with gastrointestinal stromal tumor (GIST) who have progressed after prior systemic cancer therapy.

This marks the second indication approved for Stivarga in Japan. The drug is also approved in the USA and Canada, and, along with its second-quarter results, Bayer said that Stivarga was a major contributor to growth for the firm’s new products (The Pharma Letter (July 31).

Stivarga is co-marketed in the USA with Onyx Pharmaceuticals (Nasdaq: ONXX). According to previous statements by Bayer, Stivarga has the potential for peak annual sales of 1 billion euros ($1.33 billion) with multiple approved uses.

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