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AIFA ends Zydelig monitoring registry for both authorised indications from 22 October

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency has closed registry monitoring for idelalisib in chronic lymphocytic leukaemia and follicular lymphoma, following publication of Determina DTS 56/2026 in the Official Gazette.

The Italian Medicines Agency (AIFA) has announced that monitoring in the Zydelig (idelalisib) registry ends on 22 October 2026. The decision follows publication of Determina DTS No. 56/2026 in Gazzetta Ufficiale No. 245 on 21 October 2026.

The closure covers two indications. The first is Zydelig in combination with rituximab for adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. It also covers first-line use in patients with a 17p deletion or TP53 mutation who are unsuitable for chemoimmunotherapy. The second is Zydelig as monotherapy for adults with follicular lymphoma refractory to two prior lines of treatment.

AIFA reminded clinicians how to wind down open records. When completing the end-of-treatment form, they can select 'Chiusura Monitoraggio' (monitoring closure) among the reasons for ending treatment. The date entered must be the same as, or later than, the monitoring end date, chosen using the form's calendar.

The notice, issued by AIFA's registries office, does not give reasons for the closure. It links to the full determination as a PDF.

What it means for your team

  • Hospital pharmacies and prescribing centres in Italy should use the 'Chiusura Monitoraggio' option to close open Zydelig treatment records, entering a date on or after 22 October 2026.
  • Market-access and reimbursement teams should read Determina DTS 56/2026 for any changes to conditions of access, as the notice itself states none.
  • Registry-related data collection and reporting processes for idelalisib in Italy should be updated to reflect the closure.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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