AIFA updates RYBREVANT monitoring registries to add subcutaneous dosing regimens
Italy's medicines agency has revised the amivantamab registries for two lung cancer indications, adding subcutaneous schedules and their marketing authorisation numbers from 6 November 2026.
The Italian Medicines Agency (AIFA) has updated the monitoring registries for RYBREVANT (amivantamab), with effect from 6 November 2026. The change follows the entry into force of Determination PRES/1510/2026, announced in Gazzetta Ufficiale no. 258 of 5 November 2026.
The revised registries cover two indications in advanced non-small cell lung cancer (NSCLC) with activating EGFR exon 20 insertion mutations. One is first-line treatment in adults, in combination with carboplatin and pemetrexed. The other is monotherapy in adults after platinum-based chemotherapy has failed.
Under the update, the new subcutaneous dosing regimens and their associated marketing authorisation numbers (AIC) have been added to both the drug request (RF) form and the drug dispensing (DF) form.
AIFA reminded users 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, reached through the related-links box on the agency's page. The Monitoring Registries Office published the notice, which links to the determination as a PDF.
What it means for your team
- Hospital pharmacies and prescribers in Italy should check that the RF and DF forms now show the subcutaneous regimens and AIC codes before processing amivantamab requests.
- Market-access teams should note that the registry change follows the publication of Determination PRES/1510/2026 and review it for the reimbursement conditions it sets.
- Prescribers should consult the updated clinical form for the eligibility and appropriateness criteria applying to both indications.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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