AIFA updates Tevimbra monitoring registries with new six-weekly dosing schedule and AIC codes
Italy's medicines agency has revised the Tevimbra (tislelizumab) registries for two first-line oesophageal and gastric cancer indications, effective 6 November 2026.
The Italian Medicines Agency (AIFA) has updated the monitoring registries for Tevimbra (tislelizumab), with the changes applying from 6 November 2026. The update follows the entry into force of Determination PRES/1512/2026, announced in Italy's Official Gazette no. 258 of 5 November 2026.
The revised registries cover two first-line indications in adults. One is unresectable, locally advanced or metastatic HER-2-negative gastric or gastro-oesophageal junction adenocarcinoma, treated with Tevimbra plus platinum- and fluoropyrimidine-based chemotherapy, where tumours express PD-L1 with a tumour area positivity (TAP) score of at least 5%. The other is unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma, treated with Tevimbra plus platinum-based chemotherapy, again with a TAP score of at least 5%.
In practical terms, AIFA says the Prescription Request (RF) form now includes a new dosing schedule of 400 mg every six weeks (Q6W). The Drug Dispensing (DF) form has been updated to include the new marketing authorisation numbers (AIC).
AIFA also reminded users that prescriptions 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. The notice was issued by the agency's Monitoring Registries Office, and the determination is available as a PDF on the AIFA site.
What it means for your team
- Market-access and hospital pharmacy teams in Italy should check that prescribing and dispensing workflows use the updated Tevimbra registries from 6 November 2026.
- Prescribers need to select the new 400 mg Q6W schedule in the RF form where appropriate, and dispensing staff must record the new AIC codes in the DF form.
- Regulatory affairs teams may wish to review Determination PRES/1512/2026 for the full conditions, as the notice only summarises the registry changes.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
Market accessCompany releaseMedicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filing
Market accessOfficialDenmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027
Market accessOfficialMethergin 0.2 mg/ml injection withdrawn from Danish market, DKMA reports
Market accessOfficialDenmark updates import window for estradiol 25 microgram patches in supply failure
Market accessOfficialDKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of December
Market accessOfficial