Pfizer files palbociclib NDA with FDA for breast cancer

US pharma giant Pfizer (NYSE: PFE) says it has completed the submission of a New Drug Application to the US Food and Drug Administration for its breast cancer drug candidate palbociclib.

This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

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