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AIFA ends Farydak monitoring registry for relapsed or refractory multiple myeloma from 22 October

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency says monitoring of panobinostat (Farydak) in its registry stops on 22 October 2026, following a determination published in the Official Gazette the day before.

The Italian Medicines Agency (AIFA) has told users of its monitored-drug registries that monitoring under the Farydak registry ends on 22 October 2026. The step follows publication of Determination DTS No. 53/2026 in Gazzetta Ufficiale No. 245 on 21 October 2026.

The closure applies to a single therapeutic indication: Farydak (panobinostat) in combination with bortezomib and dexamethasone for adults with relapsed and/or refractory multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent.

AIFA's Registries Office reminded clinicians that they can complete the end-of-treatment form by choosing 'Chiusura Monitoraggio' (monitoring closure) among the listed reasons for ending treatment. Prescribers must then use the calendar function to select a date that is the same as or later than the monitoring end date.

The notice, published on 22 October 2026, links to the determination as a PDF. The text provided does not describe wider changes to reimbursement or prescribing arrangements beyond the end of registry monitoring.

What it means for your team

  • Hospital pharmacies and prescribers using the Farydak registry should complete outstanding end-of-treatment forms using the 'Chiusura Monitoraggio' option.
  • When closing records, the date entered must be on or after the monitoring end date of 22 October 2026.
  • Market-access and reimbursement teams should read Determination DTS/53/2026 for the exact legal basis and any consequences for this indication.

Official source: AIFA ↗

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

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