Bayer HealthCare and Onyx Pharmaceuticals, Inc. (ONXX), on Monday announced that its metastatic colorectal cancer drug Stivarga has been approved by the Ministry of Health, Labor and Welfare in Japan.
The drug which was approved by the United States Food and Drug Administration or FDA in September last year, won approval in Japan based on data from its international multicenter pivotal Phase III CORRECT trial, which progressed at 20 sites in Japan.
Further, the drug is developed by Bayer and jointly promoted by Bayer and Onyx in the United States. Also, Bayer said that it had entered an agreement with Onyx in 2011, enabling Onyx to receive royalty on all global net sales of Stivarga in oncology.
However, Bayer in a statement added that severe and sometimes fatal hepatotoxicity was observed during clinical trials with the drug. Increased incidence of myocardial ischemia and infarction were also observed, among other effects like hemorrhage and hypertension, said Bayer.
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