The U.S. Food and Drug Administration (FDA) recently granted
priority review to
Onyx Pharmaceuticals Inc.
) Supplemental New Drug Application (sNDA) for Nexavar. Bayer and
Onyx are looking to expand Nexavar's label for the treatment of
locally advanced or metastatic radioactive iodine
(RAI)-refractory differentiated thyroid cancer.
We note that the U.S. regulatory authority generally reviews
those drugs on a priority basis which offer major advances in
treating diseases having no adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within
six months of submission as against the usual ten months.
Bayer and Onyx are looking to get Nexavar's label expanded in
both the U.S. and the EU. The companies' regulatory filing
on Nexavar was based on positive results from the phase III
DECISION (stuDy of sorafEnib in loCally advanced or metastatIc
patientS with radioactive Iodine refractory thyrOid caNcer)
Results from the study revealed a significant increase in
progression-free survival (PFS) of patients treated with Nexavar
compared to placebo (10.8 months versus 5.8 months). Data
revealed a 41% reduction in the risk of disease progression or
cases of death in patients receiving Nexavar compared to patients
We note that Nexavar is already approved for liver cancer and
advanced kidney cancer in over 100 countries around the globe.
Bayer reported Nexavar sales of €200 million in the second
quarter of 2013, up 2.6% year over year. Further label expansion
will boost Nexavar's sales. However, the oncology market is
extremely competitive given the presence of companies like
Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile, other
stocks such as
) currently look attractive carrying a Zacks Rank #1 (Strong
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