Pfizer announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the New Drug Application (NDA) for palbociclib in combination with letrozole, as a first-line treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.

The NDA submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole vs. letrozole alone in this population of patients.

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Pfizer recently initiated a multi-center, open-label expanded access program (EAP) in the U.S. for palbociclib. Through the program, palbociclib is available to post-menopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option.

Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation.

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