) Healthcare unit recently received encouraging news from the US
Food and Drug Administration (FDA) when the latter cleared the
German company's Stivarga (regorafenib) for an additional
The US regulatory body recently approved Stivarga for the
treatment of patients suffering from locally advanced,
unresectable or metastatic gastrointestinal stromal tumor (GIST).
The patients were previously treated with
) Gleevec (imatinib mesylate) and
) Sutent (sunitinib malate).
Stivarga is already available in the US for treating patients
suffering from metastatic colorectal cancer (mCRC), whose disease
had progressed even after treatment with the standard drugs
prescribed for the disease.
The FDA approval for the new indication was based on
encouraging data from a phase III study (GRID: n=199), which
evaluated patients suffering from metastatic and/or unresectable
GIST. The disease had progressed in the evaluated patients in
spite of being previously treated with Gleevec and Sutent.
Stivarga's label in the US carries a boxed warning citing the
risk of hepatotoxicity.
Notably the FDA reviewed Bayer's oncology drug on a priority
basis. We note that the US regulatory authority generally reviews
those drugs on a priority basis, which offer major advances in
treating diseases that do not have adequate therapy.
We expect the sales potential of Stivarga to be boosted
further with the approval of the new indication (GIST). The good
news came just before Bayer is gearing up for its fourth quarter
announcement. Bayer will report its financial results for the
fourth quarter and full year 2012 on Feb 28, 2013.
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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