Pfizer Provides Update on Palbociclib
The US Food and Drug Administration (FDA) has informed Pfizer Inc. that at this time there is no plan for an Oncologic Drugs Advisory Committee meeting for Ibrance (palbociclib), the company’s investigational drug to treat breast cancer.
“Pfizer continues to have an open and productive dialogue with the FDA as the application for Ibrance advances,” said the company in a release. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015. The company reports that it has entered label discussions with the FDA.
Pfizer submitted its new drug application for palbociclib in October 2014 to the FDA for approval 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. The drug received priority review by the FDA as well as breakthrough therapy designation. 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.