AIFA adds carboplatin-gemcitabine option to Imfinzi neoadjuvant NSCLC monitoring registry
Italy's medicines agency has updated the durvalumab registry for resectable non-small cell lung cancer, adding a further platinum-based combination to the neoadjuvant phase in two registry forms.
The Italian Medicines Agency (AIFA) announced on 6 November 2026 that it has updated the monitoring registry for Imfinzi (durvalumab) covering its neoadjuvant and adjuvant use in non-small cell lung cancer (NSCLC).
The registry applies to the indication in which Imfinzi is given with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi alone as adjuvant treatment. It covers adults with resectable NSCLC at high risk of recurrence who have no EGFR mutations and no ALK rearrangements.
The specific change is that carboplatin-gemcitabine has been added as an option among the combination therapies in the neoadjuvant phase. The addition appears in both the Eligibility and Clinical Data (EDC) form and the Drug Request (RF) form.
AIFA reminds prescribers that prescriptions 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, which is reached through the related links box on the notice. The notice was issued by AIFA's Monitoring Registries Office.
What it means for your team
- Prescribing centres and pharmacists using the Imfinzi neoadjuvant/adjuvant NSCLC registry should check that the carboplatin-gemcitabine option is available in the EDC and RF forms.
- Prescriptions must still comply with the eligibility and appropriateness criteria in the clinical form, so teams should download the current version from AIFA's list of active registries.
- Market-access teams tracking Italian reimbursed use of durvalumab should note the change, which concerns the registry forms and does not alter the indication wording.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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