Primary-source record
Decision-gradeFDA approval
Pfizer: FDA approves IBRANCE for HR+, HER2+ metastatic breast cancer maintenance
FDA approved IBRANCE (palbociclib) plus trastuzumab ± pertuzumab and endocrine therapy as maintenance for HR+, HER2+ locally advanced or metastatic breast cancer after induction. This is the first CDK4/6 inhibitor approval for HR+ metastatic breast cancer regardless of HER2 status, expanding IBRANCE’s label beyond its prior HR+, HER2- indications.
Key facts
- Filed
- Jun 24, 2026, 06:10 PM
- Event
- FDA approval
- Direction
- Positive
- Company
PFEPfizer- Asset
- palbociclib
- Source
- Company press release
- Confidence
- Sourced
- p value
- 0.0134
- hazard ratio
- 0.76
- risk reduction
- 24%
Source excerpt
FDA Approves Pfizer's IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance FDA Approves Pfizer's IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance 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. “Over the past decade, IBRANCE has helped transform metastatic breast cancer treatment, establishing CDK4/6 inhibition as a cornerstone of care,” said Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President, Pfizer. “With today’s FDA approval, IBRAN