Palbociclib

ATC L01EF01

articles: 2
regulatory signals: 2
cases: 0

Articles on palbociclib

Regulatory 05.11.2026

EMA: negative benefit–risk assessment of palbociclib maintenance for HR+/HER2+ metastatic breast cancer

For the proposed maintenance treatment of HR+/HER2+ metastatic breast cancer, consider that despite improved progression-free survival, the benefit–risk assessment was negative because efficacy evidence was insufficiently robust.

#palbociclib ema.europa.eu

Regulatory 05.11.2026

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

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 The application for the new maintenance use was withdrawn, not approved.

#palbociclib ema.europa.eu

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