Pfizer was granted accelerated approval from the FDA for IBRANCE (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent the confirmatory Phase III trial, PALOMA-2, which is fully enrolled.

IBRANCE was approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results of the Phase II PALOMA-1 trial.