On Wednesday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE:PFE) Ibrance (palbociclib) regimen for frontline maintenance for metastatic breast cancer.
The approval covers Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment.
FDA Expands Ibrance Use In HR+, HER2+ Breast Cancer
The approval is based on positive results from the Alliance Foundation Trials, LLC (AFT)-sponsored Phase 3 PATINA trial.
The PATINA trial demonstrated a 24% reduction in the risk of progression or death following induction treatment with the addition of IBRANCE to anti-HER2 (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapies compared to anti-HER2 and endocrine therapies alone.
