FDA sees no need for advisory panel meeting over Pfizer's Ibrance

9 January 2015

US pharma giant Pfizer (NYSE: PFE) says it has been advised by the Food and Drug Administration that at this time there is no plan for an Oncologic Drugs Advisory Committee meeting for Ibrance (palbociclib). The news sent Pfizer’s shares 2.3% higher to $32.59 on Thursday.

The drug, intended for the potential treatment of patients with breast cancer, has previously received Breakthrough Therapy designation from the FDA The Pharma Letter April 11, 2013), which is designed to expedite drug development and review. It has also gained Priority Review status.

Pfizer says it continues to have an open and productive dialogue with the FDA as the application for Ibrance advances. 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 and hopes to be able to bring Ibrance to patients who need it as soon as possible.

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