EMA reports Pfizer’s withdrawal of the application for palbociclib maintenance in HR+/HER2+ breast cancer

What it means for practice

Withdrawal of the application does not change palbociclib’s currently authorised uses or affect patients in clinical trials. The application for the new maintenance use was withdrawn, not approved.

Summary

The European Medicines Agency (EMA) reports that Pfizer has withdrawn its application to extend the indications of Ibrance (palbociclib). The application concerned maintenance treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer.

Reason for withdrawal

EMA had concerns about the efficacy evidence, particularly the risk of bias in an open-label study. Withdrawal of the application allows further data collection to address these issues. This concerns an application to extend the medicine’s use, rather than a change to its currently authorised indications.

Implications for practice and limits of the information

The withdrawal does not affect Ibrance’s already authorised uses or patients participating in clinical trials. The supplied description does not provide the study population size, treatment regimen, numerical efficacy results or a detailed explanation of the biases that raised EMA’s concerns.

Source

European Medicines Agency. Withdrawal of application to change the marketing authorisation for Ibrance (palbociclib) (VR0000316536).

Original: ema.europa.eu

Palbociclib

Reviewed by: DrugCard editorial team · 05.11.2026

This article does not replace clinical judgement. Disclaimer

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