Pfizer announced that it has submitted a New Drug Application (NDA) to the FDA for palbociclib to use 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 the advanced disease. 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.
The NDA submission is based on the final results of the PALOMA-1 trial, a randomized Phase 2 study comparing palbociclib plus letrozole vs. letrozole alone.
Previously in April 2013, palbociclib was designated Breakthrough Therapy designation by the FDA for the first-line systemic treatment of women with advanced or metastatic ER+ HER2- breast cancer.
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