Pfizer Submits NDA for Breast Cancer Drug PalbociclibBy
Pfizer Inc. has completed the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for palbociclib, an oral drug to treat advanced breast cancer. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
Palbociclib is one of Pfizer’s key late-stage new molecular entities. The 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. 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.
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.