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FDA Designation for Pfizer Candidate - Analyst Blog
Pfizer Inc. ( PFE ) was recently granted Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its oncology candidate, palbociclib (PD-0332991).
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 Novartis' ( NVS ) Femara (letrozole) compared to women on just Femara (26.1 months versus 7.5 months).
Pfizer has a collaboration agreement with Onyx Pharmaceuticals ( ONXX ) 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 cancer.
Apart from Pfizer, companies like Johnson & Johnson ( JNJ ) 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).
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
ONYX PHARMA INC (ONXX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
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