FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance
First and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status
Approval based on data from the collaborative Phase 3 PATINA trial, which showed a 24% risk reduction in disease progression for IBRANCE added to anti-HER2 and endocrine therapies
Continues decade-long legacy of IBRANCE helping transform the treatment for HR+ metastatic breast cancer
Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved IBRANCE® (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment. The approval is based on positive results from the Alliance Foundation Trials, LLC (AFT)-sponsored Phase 3 PATINA trial.
