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Vimseltinib

Extended indication First line treatment of tenosynovial giant cell tumour in adults and elderly who are not amenable to
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Vimseltinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication First line treatment of tenosynovial giant cell tumour in adults and elderly who are not amenable to surgery, monotherapy
Manufacturer Deciphera Pharmaceuticals
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2024
Expected Registration August 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Primary completion (actual): 10 augustus 2023. Deciphera heeft vimseltinib ingediend op 19 juli 2024. Uitgaande van gemiddelde doorlooptijden wordt een registratiedatum van augustus 2025 verwacht.

Therapeutic value

Current treatment options Synovectomie (verwijdering van het synoviale weefsel rond een gewricht).
Therapeutic value No estimate possible yet
Substantiation Geen farmacotherapeutische opties naast synovectomie. Resultaten van fase III MOTION trial nog niet bekend.
Frequency of administration 2 times a week
Dosage per administration 30 mg
References NCT05059262 (MOTION)

Expected patient volume per year

Patient volume

< 702

Market share is generally not included unless otherwise stated.
References Patiëntenfolder Tenosynoviale reusceltumor (TGCT). LUMC. 2024 (1).
Additional remarks Tenosynoviale reusceltumor is een zeldzame ziekte. De lokale vorm komt het meest voor en per jaar krijgen ongeveer 39 op de miljoen mensen deze diagnose (1).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.