AIFA drops brain metastases blocking field from HETRONIFLY monitoring registry eligibility form
Italy's medicines agency has revised the HETRONIFY registry for serplulimab in extensive-stage small cell lung cancer, following a determination published in the Official Gazette on 21 October 2026.
The Italian Medicines Agency (AIFA) has updated the monitoring registry for HETRONIFLY (serplulimab). The change follows publication of Determination DTS No. 57/2026 in Gazzetta Ufficiale No. 245 on 21 October 2026. AIFA announced the update on 22 October 2026.
The registry covers the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), where HETRONIFLY is used in combination with carboplatin and etoposide.
The specific change is the removal of a blocking field from the eligibility form. That field related to symptomatic brain metastases, or to patients undergoing corticosteroid therapy. With the field deleted, its presence no longer stops the eligibility form being completed in the registry.
AIFA reminded users that prescriptions for the indication reimbursed by the Italian National Health Service 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, accessible through the related links on the page.
What it means for your team
- Prescribing centres should download the updated clinical form and check that local workflows no longer rely on the deleted brain metastases and corticosteroid blocking field.
- Reimbursed use of HETRONIFLY in ES-SCLC must still follow the eligibility and appropriateness criteria in the clinical form.
- Market-access teams may wish to read Determination DTS/57/2026, published in the Official Gazette, for the full basis of the change.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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