Palbociclib regulatory update

FDA accepted and granted Priority Review to an NDA for palbociclib in combination with letrozole for first-line treatment of estrogen receptor-positive, HER2-negative, advanced breast cancer in postmenopausal women. The PDUFA date is April 13, 2015. Palbociclib has breakthrough therapy designation for the indication (see BioCentury, April 15, 2013). Pfizer began a U.S. expanded access program of palbociclib in August (see BioCentury, Sept. 15). ...