Priority Review for Pfizer's palbociclib

Pfizer Inc. (NYSE:PFE) said FDA accepted for filing and granted Priority Review to an NDA for palbociclib in combination with Femara letrozole as first-line treatment for postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer. The PDUFA date is April 13, 2015.

Palbociclib has breakthrough therapy designation in the U.S. for breast cancer. Priority Review was based on results from the Phase II PALOMA-1 trial, in which palbociclib plus Femara from Novartis AG (NYSE:NVS; SIX:NOVN) met the primary endpoint of progression-free survival (PFS) but missed the secondary overall survival endpoint. ...