Bayer’s ( BAYRY - Analyst Report ) Healthcare unit recently announced that its oncology candidate regorafenib, was granted priority review by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients suffering from unresectable and/or metastatic gastrointestinal stromal tumors (GIST).
In Dec 2012, Bayer Yakuhin Ltd., Bayer’s Japanese subsidiary, submitted a marketing authorization application for regorafenib to the MHLW in Japan. The company had earlier submitted a marketing application for the candidate in Japan for the treatment of colorectal cancer (CRC) and had received priority review in Aug 2012.
Bayer is seeking approval of the candidate on the basis of data from a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors. The disease had progressed in the evaluated patients in spite of being previously treated with Novartis’ ( NVS - Snapshot Report ) Gleevec and Pfizer’s ( PFE - Analyst Report ) Sutent.
Regorafenib is already available in the US, under the brand name of Stivarga, for treating patients suffering from metastatic colorectal cancer (mCRC), whose disease had progressed even after treatment with standard drugs prescribed for the disease. A couple of days back, Stivarga was approved for the GIST indication as well in the US. Stivarga’s label for the GIST indication in the US carries a boxed warning citing the risk of hepatotoxicity.
Bayer is also seeking EU approval of regorafenib for the treatment of mCRC.
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