AIFA updates XOSPATA monitoring registry to recognise prior quizartinib in relapsed or refractory AML
From 4 November 2026, Italy's XOSPATA (gilteritinib) registry eligibility form lists quizartinib among earlier treatments that do not rule out gilteritinib use in relapsed or refractory FLT3-mutated AML.
The Italian Medicines Agency (AIFA) has updated the monitoring registry for XOSPATA (gilteritinib) in acute myeloid leukaemia (AML), with effect from 4 November 2026. The change follows the entry into force of Determina Pres/1483/2026, announced in Gazzetta Ufficiale no. 256 of 3 November 2026.
The update applies to the indication in which XOSPATA is used as monotherapy in adults with relapsed or refractory AML carrying an FLT3 gene mutation and non-unfavourable cytogenetic risk.
Specifically, the eligibility form now includes quizartinib among prior treatments that do not preclude the use of gilteritinib in the relapsed/refractory setting. Sorafenib and midostaurina (midostaurin) were already on that list, and quizartinib is added alongside them.
AIFA reminds prescribers that prescriptions must follow the eligibility and prescribing-appropriateness criteria in the clinical form. The form can be downloaded as a .zip file from the list of active AIFA monitoring registries, linked from the notice. The notice was issued by AIFA's monitoring registries office, and the determination is available as a PDF.
As general context, AIFA monitoring registries are web-based tools through which prescribers document eligibility and treatment for certain medicines, and they underpin reimbursed access in Italy.
What it means for your team
- Prescribers in Italy treating relapsed or refractory FLT3-mutated AML should note that earlier quizartinib no longer needs to be an obstacle on the registry eligibility form for gilteritinib.
- Market-access and hospital pharmacy teams should check that local procedures and registry use align with the updated clinical form downloaded from AIFA's list of active registries.
- Regulatory affairs teams may wish to review Determina Pres/1483/2026 for the full detail of the change.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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