) 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
) Gleevec and
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
Bayer is also seeking EU approval of regorafenib for the
treatment of mCRC.
Bayer, a large cap pharma company, currently carries a Zacks
Rank #2 (Buy). Another large cap pharma stock
Eli Lilly and Company
) also carries a comparable rank.
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