AIFA updates Lunsumio monitoring registry to add subcutaneous dosing and new marketing authorisation numbers
Italy's medicines agency has revised the Lunsumio registry for relapsed or refractory follicular lymphoma, with changes effective 6 November 2026 following Determination PRES/1504/2026.
The Italian Medicines Agency (AIFA) has updated the monitoring registry for Lunsumio (mosunetuzumab), with effect from 6 November 2026. The update follows the entry into force of Determination PRES/1504/2026, announced in Gazzetta Ufficiale No. 258 of 5 November 2026.
The registry covers the use of Lunsumio as monotherapy in adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
AIFA says the change has two parts. In the drug request form (RF), the new dosing schedule for subcutaneous administration has been added. In the drug dispensing form (DF), the new marketing authorisation numbers (AIC) have been entered.
The agency also 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, reachable through the related links box on the notice. The notice was issued by AIFA's Registries Office, and the determination is available as a PDF.
What it means for your team
- Prescribers and pharmacists using the Lunsumio registry should check that the RF form now includes the subcutaneous dosing and that the DF form carries the new AIC numbers.
- Market-access and hospital pharmacy teams should confirm that internal dispensing and reimbursement workflows match the updated registry forms.
- Prescribing must still follow the eligibility and appropriateness criteria in the clinical form, so teams should download the current version from AIFA's list of active registries.
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Market accessOfficialMethergin 0.2 mg/ml injection withdrawn from Danish market, DKMA reports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