European regulators clear Bayer's Stivarga for colorectal cancer

Bayer announced Friday that the European Commission approved Stivarga (regorafenib) to treat adults with metastatic colorectal cancer (mCRC) who were previously treated with, or are not considered candidates for, available therapies. The company noted that these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy.

"Following the approval of Stivarga for mCRC in several countries worldwide, including the US and Japan, we are pleased to offer patients in Europe a new treatment option," remarked Kemal Malik, Bayer's head of global development. European approval of the oral multi-kinase inhibitor was based on results from the Phase III CORRECT trial, which were presented at the ASCO annual meeting last year.

Stivarga is jointly promoted by Bayer and Onyx Pharmaceuticals in the US, while under a 2011 agreement, the latter receives royalties on all global sales of the drug in oncology. The compound is also approved for the treatment of patients with gastrointestinal stromal tumours in several countries, including the US and Japan.

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