Study identification

EU PAS number

EUPAS25735

Study ID

49428

Official title and acronym

An International, Non-Interventional, Post-Authorization Long-Term Safety Study of Lutathera®, in Patients with Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours (SALUS Study)

DARWIN EU® study

No

Study countries

France
Portugal
Spain
United Kingdom
United States

Study description

This is a multinational, multicentre, non-interventional, retrospective and prospective study of patients with GEP-NET receiving treatment with Lutathera. This post-authorization safety study will be conducted with the aim to assess the safety profile of Lutathera and to characterize further the potential safety hazards described in the Risk Management Plan (RMP). It is part of the MAH-proposed safety management to monitor the long-term safety follow-up of Lutathera in the post-authorization setting. The SALUS study will be implemented with the objective to address the important identified risks, important potential risks, and relevant missing information from the controlled clinical trials conducted to obtain the marketing authorization of Lutathera.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Novartis Clinical Disclosure Office

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Advanced Accelerator Applications, a Novartis Company
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)