Palbociclib: Phase III start

This month, Pfizer will begin a Phase III expanded access study to evaluate 125 mg oral palbociclib once daily for the first 3 weeks of a 4-week cycle plus Femara letrozole in postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer. Early next quarter, Pfizer plans to submit an NDA to FDA for palbociclib in combination with Femara in the indication.

In April, the pharma reported that palbociclib plus Femara met the primary progression-free survival (PFS) endpoint in the Phase II PALOMA-1 trial, but missed the secondary overall survival (OS) endpoint (see BioCentury, April 14). Palbociclib has breakthrough therapy designation from FDA to treat breast cancer based on interim data from PALOMA-1 (see BioCentury, April 15, 2013). ...