AIFA updates Lunsumio monitoring registry for subcutaneous dosing in relapsed or refractory follicular lymphoma
The Italian medicines agency has amended the Lunsumio (mosunetuzumab) registry from 6 November 2026, adding the new subcutaneous posology to the request form and new AIC codes to the dispensing form.
AIFA has updated the monitoring registry for Lunsumio (mosunetuzumab), with effect from 6 November 2026. The change follows the entry into force of Determina 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 previous systemic therapies. The notice names this indication, which the agency's short summary had left unspecified.
Two changes are listed. In the RF (Richiesta farmaco, or drug request) form, users must now enter the new posology for subcutaneous administration. In the DF (dispensazione farmaco, or drug dispensing) form, the new AIC codes are to be entered.
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, reached through the 'related links' box. The determination itself is published as a PDF alongside the notice.
The same day, the agency also published registry updates for Tevimbra and Rybrevant. The source gives no details of those changes.
What it means for your team
- Market-access and hospital pharmacy teams in Italy should check that the RF and DF forms for Lunsumio now reflect the subcutaneous posology and the new AIC codes.
- Prescribers should review the updated clinical form, since eligibility and appropriateness criteria govern prescribing under the registry.
- Regulatory affairs teams may wish to read Determina PRES/1504/2026 for the underlying decision, as the notice only summarises the registry changes.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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