Pfizer’s palbociclib gains FDA Priority Review

US pharma giant Pfizer (NYSE: PFE) says that the New Drug Application for its investigational breast cancer treatment palbociclib has been accepted for filing and granted Priority Review by the US Food and Drug Administration.

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. The submission is based on the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

Market and sales forecast