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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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