PharmacovigilanceOfficial

AIFA updates Opdivo monitoring registry for two non-small cell lung cancer indications

🇮🇹 AIFA · Wed 21 Oct 2026

Italy's medicines agency has revised the nivolumab registry after a determination was published in the Official Gazette, allowing neoadjuvant immunotherapy in advanced NSCLC settings.

The Italian Medicines Agency (AIFA) has updated the monitoring registry for Opdivo (nivolumab) covering two non-small cell lung cancer (NSCLC) indications. The notice, issued by AIFA's monitoring registries office on 21 October 2026, follows publication of Determination DTS No. 49/2026 in Gazzetta Ufficiale No. 244 of 20 October 2026.

The first indication covered is Opdivo combined with ipilimumab and two cycles of platinum-based chemotherapy as first-line treatment of metastatic NSCLC in adults. Eligible tumours must have no EGFR mutations or ALK translocations and PD-L1 expression below 50%. The second is Opdivo for locally advanced or metastatic NSCLC in adults after prior chemotherapy.

The substantive change is that neoadjuvant immunotherapy is now listed among the treatments permitted in advanced NSCLC settings. This applies provided there is no disease progression, recurrence or unacceptable toxicity.

AIFA reminds users that prescriptions are to follow the eligibility and prescribing-appropriateness criteria in the clinical form, but only for the indication reimbursed by the national health service (SSN) through the publication. The form can be downloaded as a .zip file from the list of active AIFA monitoring registries, reachable from the related-links box on the notice page. The determination is attached to the notice as a PDF.

What it means for your team

  • Teams supporting Italian prescribers should check the revised clinical form in the AIFA registry list so that data entry reflects the new neoadjuvant-treatment provision.
  • Eligibility and appropriateness criteria apply only to the SSN-reimbursed indication, so internal checks should separate reimbursed from non-reimbursed use.
  • Market-access teams should read Determination DTS/49/2026 alongside the notice to confirm the exact scope of the update.

Official source: AIFA ↗

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

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