FDA approves IBRANCE® for triple positive breast cancer

The complex interactions of hormone receptors often can result in treatment resistance for patients with HR+ and HER2+ advanced breast cancer. – Image credit Penn Medicine.

CANCER DIGEST – June 27, 2026 – The U.S. Food and Drug Administration has approved the targeted drug palbociclib in combination with standard therapies for adult patients with hormone receptor-positive (HR+) and HER2-positive (HER2+) often called triple positive locally advanced or metastatic breast cancer.

The FDA approved palbociclib (IBRANCE®) in combination with trastuzumab (with or without pertuzumab) and endocrine therapy following the results of the phase III PATINA clinical trial that involved 518 patients across 109 global sites, with advanced HR+ and or HER2+ breast cancer. 

It was conducted between June 2017 through July 2021. Patients were assigned to receive either standard-of-care maintenance (anti-HER2 therapy plus endocrine therapy) alone or the same standard-of-care with the addition of palbociclib until disease progression.

HER2+) HR-Positive/HER2-Positive or "triple-positive" breast cancer is a subtype where tumor cells have hormone receptors (estrogen or progesterone) and over express the HER2 protein. Approximately 10 percent of all breast cancer cases are "double-positive" or "triple-positive." It is treated using a highly effective combination of targeted therapies, hormone treatments, and chemotherapy. 

While highly treatable, the complex interaction between hormone receptors and HER2 pathways can cause the cancer to develop resistance to treatments over time. The PATINA trial aimed to prolong the time between when initial treatment halts the progression of the cancer and when it resumes growing or advancing, called progression-free survival.

Patients in the trial treated with palbociclib in addition to standard therapy had the risk of disease progression reduced by 24 percent. The median progression-free survival was 44.3 months in the palbociclib group compared to 29.1 months for patients in the standard therapy group.

Based on those results, the FDA granted approval of palbociclib on June 24, 2026.

“PATINA answered an important clinical question and established that the addition of palbociclib to standard maintenance therapy can significantly extend progression-free survival in this patient population,” said Otto Metzger, MD, Principal Investigator of PATINA and Associate Medical Director of International Strategic Initiatives at Dana-Farber Cancer Institute. “This approval translates those findings into a new treatment option for patients and provides clinicians with another tool to help manage a complex and challenging disease.”

This information is for general educational purposes only. You must always consult a licensed oncologist or healthcare professional for clinical guidance, personal diagnosis, or treatment decisions. Always verify oncology medication details, combinations, and adverse effects directly with official pharmaceutical labeling or medical provider.

Sources: Alliance Foundation Trials, LLC press release and FDA press release