RegulatoryOfficial

AIFA ends COMETRIQ registry monitoring for medullary thyroid carcinoma indication from 22 October

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency has closed monitoring in the COMETRIQ (cabozantinib) registry for its sole listed indication, following publication of a determination in the Official Gazette.

The Italian Medicines Agency (AIFA) announced on 22 October 2026 that monitoring in the COMETRIQ (cabozantinib) registry ends that day for the indication named in its notice. The notice is addressed to users of AIFA's registries for medicines subject to monitoring.

The closure follows Determination DTS No. 52/2026, published in Gazzetta Ufficiale No. 245 on 21 October 2026. The indication concerned is the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid carcinoma.

The notice repeats the label caution on RET (Rearranged during Transfection) mutation status: where status is unknown or negative, the possibility of lower benefit should be considered before deciding on treatment for an individual patient.

For ongoing cases, clinicians can complete the end-of-treatment form by choosing "Chiusura Monitoraggio" (monitoring closure) from the list of reasons for ending treatment. The date entered, picked using the calendar tool, must be the same as or later than the monitoring end date. The notice was issued by AIFA's Monitoring Registries Office, and the determination is available as a PDF on the AIFA page.

What it means for your team

  • Hospital pharmacists and prescribing clinicians should close open COMETRIQ registry records using the "Chiusura Monitoraggio" option, with a date on or after 22 October 2026.
  • Market-access and reimbursement teams should read Determination DTS/52/2026 to confirm how the closure affects registry-linked obligations for the product.
  • Teams tracking Italian registries should update their records to show that COMETRIQ monitoring has ended 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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