BioCentury
ARTICLE | Company News

Pfizer completes palbociclib NDA submission

August 19, 2014 12:30 AM UTC

Pfizer Inc. (NYSE:PFE) completed submission of a rolling NDA to FDA for palbociclib ( PD-0332991) in combination with Femara letrozole as first-line treatment of estrogen receptor-positive, HER2-negative advanced breast cancer in postmenopausal women. According to Pfizer, the submission was based on final data from the Phase II PALOMA-1 trial, in which palbociclib plus Femara from Novartis AG (NYSE:NVS; SIX:NOVN) met the primary progression-free survival (PFS) endpoint but missed the secondary overall survival endpoint. Palbociclib has breakthrough therapy designation from FDA for breast cancer based on interim PALOMA-1 data (see BioCentury Extra, April 7). ...