FDA approves Pfizer palbociclib Ibrance for HR-positive HER2-positive advanced breast cancer maintenance
People with HR-positive, HER2-positive advanced breast cancer who respond to initial chemotherapy now have a new oral maintenance option. The FDA approved Pfizer's $PFE palbociclib, branded Ibrance, with trastuzumab and hormone therapy, based on the 518-patient PATINA trial.
People living with HR-positive, HER2-positive locally advanced or metastatic breast cancer who have responded to their initial treatment now have a new option to help keep the disease in check. On June 24, the FDA approved palbociclib, sold by Pfizer $PFE as Ibrance, in combination with trastuzumab, with or without pertuzumab, and endocrine therapy, for maintenance treatment after induction. Maintenance therapy is given once the cancer has stopped progressing, with the goal of holding that response for as long as possible. The approval is based on PATINA, a randomized, open-label trial in 518 patients with HR-positive, HER2-positive locally advanced or metastatic disease who had no evidence of progression after induction treatment with a taxane and trastuzumab, with or without pertuzumab. Palbociclib is a CDK4/6 inhibitor taken as a pill, a class already widely used in HR-positive breast cancer, and this decision extends its use into the HER2-positive maintenance setting alongside HER2-targeted and hormone therapy.