AIFA updates Rybrevant registry for first-line exon 20 insertion NSCLC, changing carboplatin regimen timing
Italy's medicines agency has revised the monitoring registry for amivantamab in advanced EGFR exon 20 insertion lung cancer, adjusting when carboplatin-containing combinations are selected on the request form.
The Italian Medicines Agency (AIFA) announced on 6 November 2026 that it has updated the monitoring registry for Rybrevant (amivantamab). The registry covers use with carboplatin and pemetrexed as first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) carrying activating EGFR exon 20 insertion mutations.
According to the notice, the change concerns the Drug Request (Richiesta Farmaco, RF) form. AIFA says the timing for selecting combination regimens that contain carboplatin has been updated. The agency gives no further detail on what the new timing is.
AIFA reminded prescribers that prescriptions must follow the eligibility and prescribing-appropriateness criteria set out in the clinical form. That form can be downloaded as a .zip file from the list of active AIFA monitoring registries, which is reachable through the related-links box on the notice page.
The notice was issued by AIFA's Registries Office (Ufficio Registri di Monitoraggio). AIFA monitoring registries are the web-based tools through which Italian centres request and track drugs subject to monitoring, and they underpin access and reimbursement for the indications concerned.
What it means for your team
- Hospital pharmacists and oncology prescribers in Italy should check the updated RF form for the carboplatin regimen selection step before submitting new requests.
- The notice does not describe the revised timing, so teams should consult the registry and the downloadable clinical form directly.
- Market-access and compliance teams may wish to review internal workflows and training for this indication to reflect the registry change.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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