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Pfizer Inc announces submission of Palbociclib new drug application to FDA


Monday, 18 Aug 2014 08:00am EDT 

Pfizer Inc:Completes submission of a New Drug Application (NDA) to United States Food and Drug Administration (FDA) for palbociclib.Says this NDA requests FDA approval of palbociclib, in combination with letrozole.Says for treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.Says submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.