FDA Approves Palbociclib for Maintenance Treatment of HR-positive, HER2-positive Metastatic Breast Cancer

The FDA has approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with hormone receptor-positive (HR+), HER2-positive (HER2+) locally advanced or metastatic breast cancer following initial induction treatment. This marks palbociclib as the first CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status, based on data from the Phase 3 PATINA trial showing a 24% reduction in the risk of progression or death.