MSD Belzutifan PAS

About

Brief Summary

This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.

This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number:

EUPAS108114

Study Type

Observational

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Greater than or equal to 18 years of age
Diagnosed with VHL disease based on a germline test or clinical diagnosis
A decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label
Signed informed consent prior to or withing 30 days after the first inititaion of belzutifan

Exclusion Criteria:

Anti-cancer systemic therapy within 2 weeks prior to the index date
Unable to consent to participate in the study
History of VHL disease-related metastasis or advanced cancer

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Study Stats

Protocol No.

24-5191