Palbociclib: Expanded access program started

Pfizer began an open-label, U.S. expanded access program to evaluate 125 mg oral palbociclib once daily for the first 21 days of a 28-day cycle in combination with 2.5 mg oral letrozole once daily in patients. Late last month, Pfizer completed submission of a rolling NDA to FDA for palbociclib in combination with letrozole as first-line treatment of estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer in postmenopausal women. Pfizer said it is seeking accelerated approval based on final data from the Phase II PALOMA-1 trial, in which palbociclib plus Femara letrozole from Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) met the primary progression-free survival (PFS) endpoint but missed the secondary overall survival endpoint (see BioCentury, April 14). ...