Palbociclib Maintenance in HER2-Positive Breast Cancer: EMA Withdrawal
October 23, 2026
Pfizer has withdrawn its European application seeking palbociclib maintenance in HER2-positive breast cancer, after the European Medicines Agency said that unresolved concerns about the efficacy evidence remained. The withdrawal followed the Committee for Medicinal Products for Human Use meeting of 12 to 15 October 2026.
Palbociclib maintenance in HER2-positive breast cancer: the PATINA data
The phase III PATINA trial randomized 518 patients with HR-positive, HER2-positive disease who had not progressed after four to eight cycles of induction chemotherapy plus HER2-targeted therapy. The trial was open label. Median investigator-assessed progression-free survival was 44.3 months with palbociclib-based maintenance and 29.1 months with anti-HER2 therapy plus endocrine therapy alone, a hazard ratio of 0.75 (95% CI 0.59 to 0.96; P=0.02). The FDA approved the regimen on 24 June 2026 on that endpoint.
Blinded central review also numerically favored palbociclib, with median progression-free survival of 69.8 months against 41.5 months. Its hazard ratio of 0.78 had a 95% CI of 0.591 to 1.041, which crossed 1.0. EMA was concerned that investigator assessment in an open-label study could be biased in favor of palbociclib, and that the central review did not confirm the benefit with equivalent certainty.
Why it matters
The FDA and EMA reached different outcomes from the same trial. The gap concerns how much confidence independent review adds to an open-label progression endpoint, not whether the drug works, since the central hazard ratio still pointed toward palbociclib. Pfizer says the withdrawal allows more data collection and analyses. The existing EU authorization of Ibrance for HR-positive, HER2-negative disease is not affected. Overall survival was not yet mature, and grade 3 or higher neutropenia occurred in 61% of patients on the US maintenance regimen. The tucatinib-based maintenance option approved in October 2026 and trastuzumab deruxtecan in first line raise the bar for new entrants.
Source: OncoDaily report on the PATINA trial and the EU withdrawal
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