Friday, April 12, 2013

Pfizer Breast Cancer Drug Gets Breakthrough Designation

A Pfizer investigational compound,palbociclib,an oral drug,has received Breakthrough Therapy designation by the FDA for the potential treatment of patients with a form of breast cancer.The designation expedites the development and review of the compound,as it is intended to treat a serious or life-threatening disease and preliminary evidence indicates the drug may demonstrate substantial improvement over existing therapies.
Pfizer has initiated a Phase 3 study evaluating palbociclib in combination with letrozole versus letrozole alone as a first line treatment for post-menopausal patients with ER+,HER2- locally advanced or metastatic breast cancer.The study is currently open and enrolling.
Preliminary Phase 2 data show that women treated with the combination of palbociclib with letrozole achieved statistically significant improvement in median survival compared to those treated with letrozole alone(26.1 months versus 7.5 months.)
Palbociclib is an inhibitor of cyclin dependent kinases,or enzymes that serve as on and off switches in tumour cells.The drug was shown to inhibit cell growth and supress DNA replication.Pfizer,the world's largest pharmaceutical company,is also investigating the drug's potential for treating other cancers.

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