Drug Approval
FDA expands Pfizer’s IBRANCE use in HER2-positive breast cancer
Backed by Phase 3 trial showing 24% lower risk of progression
- By IPP Bureau
| June 26, 2026
Pfizer has secured a major U.S. regulatory win after the FDA approved expanded use of its breast cancer therapy IBRANCE in combination with anti-HER2 and endocrine treatments for a broader patient population.
The FDA has cleared IBRANCE for maintenance treatment of adults with hormone receptor-positive (HR+), HER2-positive locally advanced or metastatic breast cancer following induction therapy—marking a significant expansion in how the drug can be used in combination regimens that already include trastuzumab, with or without pertuzumab, plus endocrine therapy.
The approval is backed by results from the Phase 3 PATINA trial sponsored by Alliance Foundation Trials, which showed a meaningful improvement in in outcomes when IBRANCE was added to standard maintenance therapy.
According to the study, patients experienced a 24% reduction in the risk of disease progression or death compared with standard treatment alone.
“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, IBRANCE becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance.
"This milestone strengthens confidence in IBRANCE as a CDK4/6 inhibitor backbone across combination regimens, reflecting Pfizer's ongoing leadership in delivering meaningful advances for people with breast cancer."
