PALOMA-1 trial results of Ibrance (palbociclib)for Breast Cancer published in The Lancet Oncology- Pfizer

Pfizer Inc. announced the publication of the detailed results from PALOMA-1, a randomized Phase II study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology. As previously disclosed, PALOMA-1 achieved its primary endpoint with the combination of palbociclib and letrozole significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic Breast Cancer. A New Drug Application (NDA) for palbociclib was accepted for filing and granted Priority Review by the FDA This NDA is based on the final results of PALOMA-1. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015. Ibrance is the proposed trade name for palbociclib.