) was recently granted Breakthrough Therapy Designation from the
US Food and Drug Administration (FDA) for its oncology candidate,
The designation was granted for the potential treatment of
breast cancer patients. The designation, which was enacted as
part of the 2012 Food and Drug Administration Safety and
Innovation Act, is granted to potential new treatments for
serious or life-threatening diseases or conditions where the
initial clinical data shows that the treatment has the potential
to demonstrate substantial improvement on one or more clinically
significant endpoints compared to existing treatments. The
designation should help fasten the development and review process
for the candidate.
Palbociclib is one of the most promising candidates in
Pfizer's oncology pipeline. Interim data showed that a
statistically significant improvement in median progression free
survival was achieved in women treated with palbociclib plus
) Femara (letrozole) compared to women on just Femara (26.1
months versus 7.5 months).
Pfizer has a collaboration agreement with
) for palbociclib, an oral and selective inhibitor of cyclin
dependent kinases (CDK) 4 and 6.
Palbociclib is currently in a randomized, multi-center,
double-blind phase III study (Study 1008) which is evaluating
palbociclib plus Femara as a first-line treatment compared to
Femara alone. The study is being conducted in post-menopausal
patients with ER+, HER2- locally advanced or metastatic breast
Apart from Pfizer, companies like
Johnson & Johnson
) and Novartis have also received Breakthrough Therapy
Designation for specific oncology candidates.
Currently, Pfizer carries a Zacks Rank #3 (Hold). In the
large-cap pharma space, Novartis looks well-positioned with a
Zacks Rank #2 (Buy).
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