FDA accepts for review Ibrance (palbociclib) + fulvestrant to treat human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer.- Pfizer

December 2015- Pfizer Inc. announced that the FDA has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication,Ibrance (palbociclib). If approved, the sNDA would expand the approved use of Ibrance to reflect findings from the Phase III PALOMA-3 trial.

This trial evaluated Ibrance in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.

Comment: Based on the results of the PALOMA-1 trial, Ibrance was approved by the FDA in February 2015 for use in combination with letrozole as a treatment for postmenopausal women with estrogen receptor-positive (ER+), HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial, PALOMA-2.