AIFA updates Enhertu monitoring registries, lifting block on patients with brain metastases
Italy's medicines agency has revised the registries for trastuzumab deruxtecan in breast and gastric cancer, removing a treatment block for patients with active, symptomatic or uncontrolled brain metastases.
The Italian Medicines Agency (AIFA) has announced that the monitoring registries for Enhertu (trastuzumab deruxtecan) were updated from 6 November 2026. The change follows the entry into force of Determina PRES/1529/2026, notice of which appeared in the Gazzetta Ufficiale no. 258 of 5 November 2026.
The updated registries cover three therapeutic indications. Two are in breast cancer: unresectable or metastatic HER2-positive disease in adults who have had one or more prior anti-HER2-based regimens, and unresectable or metastatic HER2-low disease in adults who have had prior chemotherapy for metastatic disease or relapsed during or within six months of finishing adjuvant chemotherapy. The third is advanced HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults previously treated with a trastuzumab-based regimen.
According to AIFA, the specific change is the removal of the treatment block for patients with brain metastases that are active, symptomatic or uncontrolled. The notice does not explain the reasoning behind the change.
AIFA reminds prescribers that prescriptions must follow the eligibility and prescribing-appropriateness criteria in the clinical form. The form can be downloaded as a .zip file from the list of active AIFA monitoring registries, accessible via the related-links box on the notice page. The determination is available as a PDF alongside the announcement, which was issued by AIFA's Monitoring Registries Office.
What it means for your team
- Italian prescribers and hospital pharmacies should check the revised clinical forms before enrolling patients with brain metastases in the Enhertu registries.
- Market-access teams should note that registry criteria govern reimbursed access, and review the text of Determina PRES/1529/2026 for the full detail.
- Internal prescribing guidance and registry-related training materials may need updating to reflect the removal of the block.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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