Recently, the HealthCare unit of
) announced that its oncology drug Stivarga (regorafenib) will be
reviewed on a priority basis by the US Food and Drug
Administration (FDA). Bayer is looking to get Stivarga, an oral
multi-kinase inhibitor, approved for treating patients suffering
from metastatic and/or unresectable gastrointestinal stromal
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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. Applications for
priority review designated drugs are reviewed by the FDA within
six months of submission as against the usual ten months.
The new drug application (NDA), seeking approval of Stivarga for
the GIST indication, was filed by Bayer in August 2012. The NDA
was submitted on the basis of 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
) Gleevec and
We remind investors that Stivarga was approved in the US in
September 2012 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
approval was based on encouraging data from a pivotal phase III
study (CORRECT: n=760). Bayer and
Onyx Pharmaceuticals, Inc.
), as per an agreement inked last year, co-promote Stivarga in
The sales potential of Stivarga would be further boosted if the
FDA clears the drug for the GIST indication.
We have an Outperform recommendation on Bayer. The stock carries
a Zacks #2 Rank (Buy rating) in the short run.