UPDATE: Pfizer Announces Will Submit Palbociclib NDA Early in Q3

Pfizer Inc. (NYSE: PFE) today announced that it will submit a New Drug Application (NDA)with the United States Food and Drug Administration (FDA) for palbociclib,combined with letrozole, as first-line systemic treatment of post-menopausalwomen with estrogen receptor positive (ER+), human epidermal growth factorreceptor 2 negative (HER2-) locally advanced or metastatic breast cancer.Pfizer expects to submit the NDA early in the third quarter of this year. Thisdecision was based on discussions with the FDA regarding the final results ofPALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozoleversus letrozole alone in this population of patients.Palbociclib received Breakthrough Therapy designation from the FDA in April2013, for the first-line systemic treatment of women with advanced ormetastatic ER+, HER2- breast cancer. This designation was based on interimdata from the PALOMA-1 trial.