BioCentury
ARTICLE | Company News

Pfizer planning palbociclib submission

May 17, 2014 12:18 AM UTC

Pfizer Inc. (NYSE:PFE) said it plans to submit an NDA to FDA early next quarter for palbociclib in combination with Femara letrozole from Novartis AG (NYSE:NVS; SIX:NOVN) as first-line treatment of estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer in postmenopausal women. Pfizer said the decision was based on discussions with FDA regarding final data from the Phase II PALOMA-1 trial. Last month, the pharma reported that palbociclib plus Femara met the primary progression-free survival (PFS) endpoint in the trial, but missed the secondary overall survival (OS) endpoint. Palbociclib has breakthrough therapy designation from FDA to treat breast cancer based on interim data from PALOMA-1 (see BioCentury Extra, April 7). ...