Pfizer Inc. today announced the New Drug Application (NDA) for
palbociclib has been accepted for filing and granted Priority Review by
the United States Food and Drug Administration (FDA). This NDA requests
FDA approval of palbociclib, in combination with letrozole, as a
first-line treatment for 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.
By Chelsey Dulaney
Pfizer Inc. said Monday that its experimental breast-cancer treatment, palbociclib, has been granted priority review by the U.S. Food and Drug Administration, potentially speeding the approval process by up to four months.
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