Early FDA approval for Pfizer breast cancer drug Ibrance

The US Food and Drug Administration yesterday granted accelerated approval for pharma giant Pfizer’s (NYSE: PFE) Ibrance (palbociclib) to treat advanced (metastatic) breast cancer, making this the first-ever marketing clearance for the drug. Pfizer’s shares rose 0.9% to $32.30 on moderate volume in after-hours trading.

The FDA said it granted Ibrance breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. It also received a priority review, which provides for an expedited review of drugs intended to provide a significant improvement in safety or effectiveness in the treatment of a serious condition or meet an unmet medical need. Ibrance is being approved more than two months ahead of the prescription drug user fee goal date of April 13, 2015, the date when the agency was scheduled to complete its review of the application, the FDA noted.

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