Pfizer to file palbociclib at FDA for Metastatic Breast Cancer

Pfizer Inc. has announced that it will submit a New Drug Application (NDA) with the 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 II 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.