The HealthCare unit of
) recently announced that the US Food and Drug Administration (FDA)
has cleared its oncology candidate, Stivarga (regorafenib). The FDA
approved Stivarga, an oral multi-kinase inhibitor, for use in
treatment-experienced metastatic colorectal cancer patients.
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We note that the FDA reviewed the new drug application (NDA),
submitted in April 2012, for Stivarga on a priority basis. 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. Priority review status means that the FDA
will review the marketing application within six months instead of
the standard ten months.
The approval came in on the basis of encouraging data from a
pivotal phase III study (CORRECT: n=760), which evaluated Stivarga
in metastatic colorectal cancer patients, whose disease had
progressed even after treatment with the standard drugs prescribed
for the disease. Statistically significant improvement in overall
survival (OS) and progression free survival (PFS) were observed in
the Stivarga arm compared to placebo.
Stivarga is being reviewed on a priority basis in Japan for
treating patients suffering from metastatic colorectal cancer,
whose disease has progressed despite prior treatment. Bayer is also
seeking European approval for the candidate for the indication.
Bayer is also looking to get Stivarga approved for treating
patients suffering from metastatic and/or unresectable
gastrointestinal stromal tumors (GIST). The company is seeking
approval on the basis of encouraging 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
) Sutent. The data was presented at the June 2012 annual conference
of the American Society of Clinical Oncology (ASCO).
Onyx Pharmaceuticals, Inc.
), as per an agreement inked last year, will co-promote Stivarga in
the US. Onyx will receive royalties on net sales of Stivarga.
We remind investors that last month
) colorectal cancer drug, Zaltrap, received approval. The FDA
approved Zaltrap as a combination therapy for treating patients
suffering from metastatic colorectal cancer who are either
resistant to or whose disease has progressed following treatment
with an oxaliplatin-containing regimen.
We have an Outperform recommendation on Bayer. The stock carries a
Zacks #1 Rank (Strong Buy rating) in the short run.