MSD Belzutifan PAS
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
detailed description
Primary Objective
* Among new users of belzutifan with VHL disease-associated RCC, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or locally directed therapy (e.g., radiofrequency ablation). * Among new users of belzutifan with VHL disease-associated CNS hemangioblastoma, to describe the proportion of patients who undergo at least one CNS tumor reductive surgery (e.g., craniectomy) or locally directed therapy (e.g., radiation therapy).
Secondary Objectives
Among all new users of belzutifan to describe:
\- Proportion of patients with treatment emergent SAEs, including the nature of these events.
Treatment patterns including the:
* Duration of therapy * Proportion of patients who discontinued treatment, time to treatment discontinuation, and summary of reasons for discontinuation * Proportion of patients who interrupted treatment, time to treatment interruption, duration of treatment interruption, and summary of reasons for treatment interruption * Proportion of patients with dose reductions, and reason for dose reduction. * Among new users of belzutifan with VHL disease-associated RCC and, separately, VHL disease-associated CNS hemangioblastoma, to describe: * Proportion of patients who develop metastatic disease (for RCC only) * Proportion of patients with occurrence of new VHL disease-associated tumor or tumor type
official title
Non-interventional Post-authorization Study of Belzutifan in Adult Patients With Von Hippel-Lindau Disease-associated Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor and/or Central Nervous System Hemangioblastoma (MK-6482-026)