RegulatoryOfficial

AIFA ends XALKORI registry monitoring for ROS1-positive advanced NSCLC from 22 October

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency says monitoring of crizotinib in advanced ROS1-positive non-small cell lung cancer stops on 22 October 2026, following publication of a determination in the Official Gazette.

The Italian Medicines Agency (AIFA) has announced that monitoring in the XALKORI (crizotinib) registry will end on 22 October 2026 for one therapeutic indication. The notice, published by AIFA's Registries Monitoring Office on the same date, is addressed to users of the agency's monitored-medicines registries.

The affected indication is XALKORI as monotherapy for adult patients with advanced ROS1-positive non-small cell lung cancer. The closure follows the publication of Determination DTS No. 55/2026 in Gazzetta Ufficiale No. 245 of 21 October 2026. The determination is available as a PDF linked from the notice.

AIFA reminds clinicians that they can complete the end-of-treatment form by selecting 'Chiusura Monitoraggio' (monitoring closure) from the listed reasons for ending treatment. Doing so requires choosing, with the help of the calendar function, a date equal to or later than the monitoring end date.

The notice does not explain why monitoring is ending for this indication, and it does not give any safety rationale. It also does not say whether registry monitoring continues for any other XALKORI indications.

What it means for your team

  • Teams supporting Italian prescribing centres should check open XALKORI registry records for the ROS1-positive advanced NSCLC indication and ensure end-of-treatment forms use the monitoring closure option.
  • The closure date entered must be on or after the monitoring end date, 22 October 2026.
  • Market-access and regulatory staff should consult Determination DTS/55/2026 for the full detail, since the notice gives no reasoning and does not address other indications.

Official source: AIFA ↗

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

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