FDA Approves Palbociclib-Based Maintenance for Patients With HR-Positive, HER2-Positive Advanced Breast Cancer

Clinical Summary:

• Based on results from the phase 3 PATINA trial, the FDA has approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy. 
• The addition of palbociclib significantly improved progression-free survival compared with anti-HER2 therapy and endocrine therapy alone, with a safety profile consistent with prior experience. 
• This approval provides a new maintenance treatment option for patients with HR-positive, HER2-positive advanced breast cancer following initial disease control with induction therapy.

On June 24, 2026, the US Food and Drug Administration (FDA) approved palbociclib (Ibrance, Pfizer) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment. This approval was based on results from the phase 3 PATINA trial. 

In this open-label trial, 518 patients who had no evidence of disease progression after induction therapy with a taxane and trastuzumab, with or without pertuzumab, were randomized 1:1 to receive either palbociclib plus trastuzumab, with or without pertuzumab, and endocrine therapy or trastuzumab, with or without pertuzumab, and endocrine therapy alone. Endocrine therapy consisted of fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane). Treatment continued until disease progression or unacceptable toxicity.

The primary end point was investigator-assessed progression-free survival (PFS). A key secondary end point was overall survival (OS). 

At analysis, palbociclib significantly improved PFS compared with anti-HER2 therapy and endocrine therapy (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.59 to 0.97; one-sided P = .0134). The median PFS could not be adequately characterized because of censoring. OS data were not mature at the time of the PFS analysis.

The recommended dose of palbociclib is 125 mg orally once daily for 21 consecutive days followed by 7 days off treatment in a 28-day cycle. Treatment is administered in combination with trastuzumab, with or without pertuzumab, and endocrine therapy until disease progression or unacceptable toxicity.

Prescribing information for palbociclib includes warnings and precautions for neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

Source:

US Food and Drug Administration. FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer. Accessed June 24, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance