UPDATE: Pfizer Announces Will Submit Palbociclib NDA Early in Q3

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Pfizer Inc.
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-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Pfizer expects to submit the NDA early in the third quarter of this year. This decision was based on discussions with the FDA regarding the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.
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