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FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance in HR+/HER2- metastatic breast cancer

On June 24, 2026, the U.S. Food and Drug Administration (FDA) approved palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for adults with hormone receptor-positive, HER2-positive metastatic breast cancer following induction therapy.1 Despite the advent of HER2-targeted therapies in this space, most patients eventually experience disease progression, and prolonged exposure to chemotherapy can be associated with cumulative toxicity and reduced quality of life. For patients with hormone receptor-positive, HER2-positive disease in particular, combining HER2-targeted therapies with endocrine-based approaches represents a promising avenue to address this unmet need.2

The approval was supported by results from the Phase III PATINA trial (NCT02947685), which recruited 518 patients to randomly receive palbociclib or standard therapy in a 1:1 fashion. The primary endpoint was investigator-assessed progression-free survival and secondary endpoints included the objective response, clinical benefit, safety, and overall survival. Addition of palbociclib resulted in statistically significant improvement in progression-free survival (PFS).  Median PFS was 44.3 months in the palbociclib arm compared with 29.1 months in the control arm (HR 0.74, 95% CI: 0.58, 0.94). The safety profile was consistent with the established toxicities of palbociclib, and no new safety signals were identified.3

Erika Hamilton, MD, Sarah Cannon Research Institute, Nashville, TN, comments on the significance of the trial data, saying:

“We have PATINA data, which is another trial that looked at the maintenance setting. PATINA was only for patients that had a hormone receptor positive disease. But really the magnitude of benefit in PATINA was very impressive … The control arm in PATINA was a PFS of 29 months, improved up to 44 months.”

This approval represents an important advance for patients with hormone receptor-positive, HER2-positive metastatic breast cancer, establishing a new maintenance treatment option capable of significantly extending disease control while potentially delaying the need for additional chemotherapy-based therapies.

References:

  1. Center for Drug Evaluation and Research. FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer [Internet]. U.S. Food and Drug Administration. 2026 [cited 2026 Jun 24]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
  2. Ran R, Ma Y, Wang H, Yang J, Yang J. Treatment strategies for hormone receptor-positive, human epidermal growth factor receptor 2-positive (HR+/HER2+) metastatic breast cancer: A review. Frontiers in Oncology. 2022 Dec 23;12. doi:10.3389/fonc.2022.975463
  3. Metzger O, Mandrekar S, Goel S, Gligorov J, Lim E, Ciruelos E, et al. Palbociclib for hormone-receptor–positive, HER2-positive advanced breast cancer. New England Journal of Medicine. 2026 Jan 29;394(5):451–62. doi:10.1056/nejmoa2511218