Market accessOfficial

AIFA updates Enhertu monitoring registries, lifting treatment block for patients with brain metastases

🇮🇹 AIFA · Fri 06 Nov 2026

Italy's medicines agency has revised the registries for Enhertu in breast and gastric cancer, removing a block on treating patients with active, symptomatic or uncontrolled brain metastases.

The Italian Medicines Agency (AIFA) announced on 6 November 2026 that the monitoring registries for Enhertu (trastuzumab deruxtecan) have been updated, with effect from that date. The change follows the entry into force of Determination PRES/1529/2026, notified in Gazzetta Ufficiale No. 258 of 5 November 2026.

The updated registries cover three indications: HER2-positive breast cancer, HER2-low breast cancer and gastric cancer. In HER2-positive disease, Enhertu monotherapy is for adults with unresectable or metastatic cancer who have had one or more prior anti-HER2 regimens. In HER2-low disease, it is for adults with unresectable or metastatic cancer who have had chemotherapy for metastatic disease, or whose disease recurred during or within six months of finishing adjuvant chemotherapy. In gastric cancer, it is for adults with advanced HER2-positive adenocarcinoma of the stomach or gastro-oesophageal junction who have had a prior trastuzumab-based regimen.

AIFA said the specific change is the removal of the treatment block for patients with active, symptomatic or uncontrolled brain metastases. The notice does not give further detail on how the revised registry fields operate.

AIFA reminded prescribers that prescriptions must follow the eligibility and prescribing-appropriateness criteria set out in the clinical form. The form can be downloaded as a .zip file from the list of active AIFA monitoring registries, which is linked from the notice. The determination is published as a PDF alongside the announcement.

What it means for your team

  • Market-access and hospital teams in Italy should check that local prescribing workflows reflect the removal of the brain-metastases block in the three Enhertu registries.
  • Prescribers should use the updated clinical form from the active registries list, as eligibility and appropriateness criteria still apply.
  • Regulatory teams can consult Determination PRES/1529/2026 (Gazzetta Ufficiale No. 258, 5 November 2026) for the formal basis of the change.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

More Market access All →