AIFA updates Tevimbra monitoring registries with new six-weekly dosing schedule and AIC codes
Italy's medicines agency has revised the registries for tislelizumab in gastric/GEJ adenocarcinoma and oesophageal squamous cell carcinoma, effective 6 November 2026, following Determination PRES/1512/2026.
The Italian Medicines Agency (AIFA) has updated the monitoring registries for Tevimbra (tislelizumab), with changes applying from 6 November 2026. The update follows the entry into force of Determination PRES/1512/2026, announced in Gazzetta Ufficiale No. 258 of 5 November 2026.
The revised registries cover two first-line indications. The first is Tevimbra combined with platinum- and fluoropyrimidine-based chemotherapy for adults with unresectable, locally advanced or metastatic HER-2-negative gastric or gastro-oesophageal junction adenocarcinoma, whose tumours express PD-L1 with a tumour area positivity (TAP) score of at least 5%. The second is Tevimbra with platinum-based chemotherapy for adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma, also with PD-L1 TAP of at least 5%.
In practical terms, AIFA says the prescription request form (RF) now includes a new dosing schedule of 400 mg every six weeks (Q6W). The dispensing form (DF) has been updated to include the new marketing authorisation numbers (AIC).
AIFA reminds prescribers that treatment must follow the eligibility and prescribing appropriateness criteria set out in the clinical form. This can be downloaded as a .zip file from the list of active AIFA monitoring registries, accessible through the related links on the notice. The notice comes from AIFA's Monitoring Registries Office and links to the determination as a PDF.
What it means for your team
- Prescribing centres in Italy should check that requests for Tevimbra use the new 400 mg Q6W option in the RF form where applicable.
- Pharmacy and dispensing teams need to record the new AIC codes in the DF form.
- Market-access teams should note that prescriptions remain subject to the eligibility and appropriateness criteria in the registry's clinical form.
- Determination PRES/1512/2026 is the underlying legal basis and should be consulted for full details.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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