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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.
Pfizer’s first-in-class palbociclib (Ibrance), its breast cancer drug that is expected to be a blockbuster treatment, will not be presented to an Oncologic Drugs Advisory Committee advisory panel, the company reported Jan. 8, 2015. The company is reportedly already in label discussions with FDA, indicating that an approval may be in the near future.
The anticipated approval date is Apr. 13, 2015, however, some analysts report the absence of a panel may allow the decision to come prior to the scheduled Prescription Drug User Fee Act (PDUFA) date.
FDA granted Pfizer’s investigational medication Priority Review status and was later granted a Breakthrough Therapy designation. Pfizer is seeking approval for palbociclib as a first-line therapy for treatment-naïve postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The drug works by selectively inhibiting CDK4 and CDK6. Both CDK4 and CDK6 are thought to promote uncontrolled cell growth and inhibit both cell senescence and apoptosis.