FDA Approves Ibrance Combo for Maintenance Treatment of HR-Positive, HER2-Positive Metastatic Breast Cancer

The Food and Drug Administration (FDA) on June 24, 2026, approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and hormone-blocking therapy for the maintenance treatment — meaning ongoing treatment to keep cancer from coming back — of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer who have already completed initial treatment. Ibrance is manufactured by Pfizer Inc.

The PATINA Trial

The approval was based on findings from the PATINA trial, a clinical study that enrolled 518 patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer whose cancer had not gotten worse after completing initial chemotherapy with trastuzumab, with or without pertuzumab.

Patients were randomly divided into two equal groups. One group received Ibrance added to their existing regimen of trastuzumab, with or without pertuzumab, plus hormone-blocking therapy — which included drugs like fulvestrant, anastrozole, letrozole, or exemestane. The other group received trastuzumab, with or without pertuzumab, and hormone-blocking therapy alone, without Ibrance. All patients continued treatment until their cancer progressed or side effects became too difficult to manage.

Progression-Free Survival Results

The main goal of the trial was to measure progression-free survival — how long patients lived without their cancer getting worse.

Adding Ibrance to the regimen significantly reduced the risk of cancer progression or death by 24% compared to the regimen without Ibrance. The hazard ratio was 0.76, meaning patients in the Ibrance group were less likely to see their cancer worsen at any given point in time. The median time to progression could not be calculated because many patients had not yet experienced disease progression at the time of the analysis. Data on overall survival — how long patients lived overall — were not yet available.

Recommended Dose and Administration

The recommended dose of Ibrance is 125 milligrams taken by mouth once daily for 21 days, followed by 7 days off, repeating in 28-day cycles. Patients continue this schedule until their cancer progresses or side effects become unmanageable. Dosing for trastuzumab, pertuzumab, and hormone-blocking therapy should follow the guidance of a treating physician.

Key Side Effects and Warnings

Important warnings for Ibrance include a risk of low white blood cell counts (neutropenia), which can increase the chance of infection; lung inflammation (interstitial lung disease or pneumonitis); and harm to an unborn baby (embryo-fetal toxicity). Patients who are pregnant or may become pregnant should talk with their doctor about these risks before starting treatment.

Ibrance received breakthrough therapy designation for this use, a designation the FDA grants to treatments that show early promise in addressing serious conditions.

References

1. "FDA Approves Palbociclib (Ibrance) With Trastuzumab, With or Without Pertuzumab, and Endocrine Therapy for Maintenance Treatment of HR-Positive, HER2-Positive Metastatic Breast Cancer." U.S. Food and Drug Administration. June 24, 2026.

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