Pfizer’s Palbociclib Granted FDA Priority Review For ER+ Breast Cancer Treatment

Pfizer’s Palbociclib Granted FDA Priority Review For ER+ Breast Cancer Treatment
shutterstock_149771528Pfizer Inc. has announced that the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). This NDA will depend on the FDA’s approval of palbociclib, in combination with letrozole, as a first-line treatment for 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. Palbociclib is an investigational oral drug that inhibits cyclin-dependent kinases (CDKs) 4 and 6. This blockade allows a tight control of the cell cycle and inhibits tumor cell proliferation, since the majority of cancers exhibit an over-activation of these two cyclins, resulting in uncontrolled tumor growth. Data gathered from different preclinical studies has demonstrated that in ER+ breast cancer cell lines that have an increased activity of CDK4/6, inhibition of both these cyclins together with ER signaling can stop tumor cell proliferation. Pfizer’s NDA submission is based on the promising results of the PALOMA-1 clinical study, a randomized, Phase 2 trial comparing 125mg of palbociclib on
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