The HealthCare segment of
) recently announced that the Ministry of Health, Labor and
Welfare (MHLW) in Japan approved Stivarga for the treatment of
patients suffering from gastrointestinal stromal tumor (GIST) who
have progressed following prior systemic cancer therapy.
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The drug's approval was based on positive results from Bayer's
phase III GRID (GIST - Regorafenib In Progressive Disease) study.
Bayer enrolled 199 patients for the study suffering from
metastatic and/or unresectable GIST and whose disease has
progressed in spite of being previously treated with
) Gleevec (imatinib mesylate) and
) Sutent (sunitinib malate).
Results from the study revealed that patients treated with
Stivarga showed a statistically significant improvement in
progression-free survival (PFS) in comparison to patients under
placebo. Stivarga is also approved in the U.S. for the GIST
We note that this is Stivarga's second approval in Japan. In Mar
2013, the drug was approved for the treatment of patients
suffering from unresectable, advanced/recurrent colorectal cancer
Stivarga is already approved in the U.S. for treating patients
suffering from metastatic CRC (mCRC), whose disease has
progressed even after treatment with standard drugs. Bayer is
also seeking EU approval of Stivarga for the treatment of mCRC.
In Jul 2013, Bayer received a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) for the approval of Stivarga in the mCRC
A final decision from the EU regulatory authorities on the
approval of Stivarga is expected by Dec 31, 2013. We note that
though the European Commission is not bound to follow the CHMP's
decision, it generally does so. We believe that further market
expansion will boost the drug's sales potential.
Bayer presently carries a Zacks Rank #3 (Hold). However, other
pharma stocks, such as
), currently look better positioned with a Zacks Rank #1 (Strong