AIFA updates XOSPATA monitoring registry to allow prior quizartinib in relapsed or refractory AML
From 4 November 2026, the eligibility form for gilteritinib in FLT3-mutated relapsed or refractory acute myeloid leukaemia lists quizartinib among permitted earlier treatments.
Italy's medicines agency AIFA has updated the monitoring registry for XOSPATA (gilteritinib) 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 adult patients with relapsed or refractory acute myeloid leukaemia (AML) who carry an FLT3 gene mutation and have non-unfavourable cytogenetic risk.
Specifically, the eligibility form now includes quizartinib among the previous treatments that do not preclude the use of gilteritinib in the relapsed or refractory setting. Sorafenib and midostaurina (midostaurin) were already listed as non-preclusive prior therapies.
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, accessible via the related links on the notice. The Monitoring Registries Office published the notice on 4 November 2026.
What it means for your team
- Prescribing centres should check that registry eligibility entries for XOSPATA reflect the revised list of non-preclusive prior treatments, now including quizartinib.
- Market-access and hospital pharmacy teams should align internal prescribing and data-entry guidance with the updated clinical form from the AIFA registry list.
- Teams can consult Determina Pres/1483/2026, published as a PDF alongside the notice, for the underlying decision.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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