NAPSR News: Pfizer receives FDA Priority Review for breast cancer drug palbociclib

WASHINGTON - Oct. 13, 2014 - PRLog -- The United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for Pfizer's palbociclib. The NDA submitted requests approval of palbociclib, in combination with letrozole. This will be introduced 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 targeted agent that selectively obstructs cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell production, the drug received Breakthrough Therapy designation from the FDA in April 2013 for first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. Submission data for the Priority Review was based on the results of the PALOMA-1 study, which is a randomized, Phase 2 trial which compared palbociclib plus letrozole versus letrozole alone. The palbociclib/letrozole combination increased progression-free survival (PFS) by around 50% compared to letrozole alone.

The priority review designation for this therapy will accelerate the review time from 10 months to a goal of six months from the day of acceptance of filing. The priority review designation is normally allocated to drug applications to treat serious conditions and pending regulatory approval, improve safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies. Pfizer anticipates the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA to be April 13, 2015. “If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer,” said Garry Nicholson, president, Pfizer Oncology. “We look forward to continuing to work closely with the FDA through the review process.”

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