Extended indication In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma
Therapeutic value No estimate possible yet
Total cost 339,245,250.00
Registration phase Clinical trials

Product

Active substance Belzutifan
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Kidney cancer
Extended indication In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma
Manufacturer Peloton
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks MoA: Endothelial PAS domain-containing protein 1 inhibitors

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Het geneesmiddel wordt onderzocht in een tweedelijnsstudie na eerdere behandeling met anti PD-1/L1. In Nederland wordt vaak eerstelijns ipilumab/nivolumab ingezet.
Frequency of administration 1 times a day
Dosage per administration 120 mg
References NCT04586231; Motzer RJ, Schmidinger M, Eto M, Suarez C, Figlin R, Liu Y, Perini R, Zhang Y, Heng DY. LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. Future Oncol. 2023 Jan;19(2):113-121. doi: 10.2217/fon-2022-0802. Epub 2023 Feb 8. PMID: 36752726.

Expected patient volume per year

Patient volume

< 995

Market share is generally not included unless otherwise stated.

References IKNL 2021
Additional remarks In 2021 werden er 411 diagnoses stadium III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV.

Expected cost per patient per year

Cost < 340,950.00
References drugs.com
Additional remarks Amerikaanse prijs is $330.61 per 40 gram. Uitgaande van 120mg per dag zou dat voor een heel jaar behandelen maximaal uitkomen op minder dan €340.950. Behandelduur is echter nog niet bekend.

Potential total cost per year

Total cost

339,245,250.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Adis Insight
Additional remarks Geen andere fase 3 studies

Other information

There is currently no futher information available.