PharmacovigilanceOfficial

AIFA drops brain-metastasis blocking field from HETRONIFLY monitoring registry for extensive-stage SCLC

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency has revised the eligibility form for serplulimab in first-line ES-SCLC, following publication of Determina DTS n. 57/2026 in the Official Gazette.

The Italian Medicines Agency (AIFA) has updated the monitoring registry for HETRONIFLY (serplulimab), after Determina DTS n. 57/2026 appeared in Gazzetta Ufficiale No. 245 on 21 October 2026. AIFA announced the change on 22 October 2026.

The registry covers the indication in which HETRONIFLY is given with carboplatin and etoposide as first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC).

The specific change is to the eligibility form, where AIFA has removed a blocking field. The field had concerned symptomatic brain metastases or ongoing corticosteroid therapy. The notice does not give the reasons for the removal.

AIFA also reminded users that prescriptions for the indication reimbursed by the National Health Service, as set out in the published determination, 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, which is linked from the notice.

What it means for your team

  • Prescribing centres should use the updated HETRONIFLY registry form, in which the brain-metastasis and corticosteroid blocking field no longer appears.
  • Market-access and pharmacy teams should check that internal guidance and reimbursement eligibility checks reflect Determina DTS n. 57/2026.
  • Reimbursed prescribing remains tied to the criteria in the clinical form, which is available from AIFA's list of active monitoring registries.

Official source: AIFA ↗

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

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