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Bezuclastinib

Extended indication Tweedelijnsbehandeling van lokaal gevorderde, gemetastaseerde en/of niet-reseceerbare PDGFR-negatiev
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Bezuclastinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Tweedelijnsbehandeling van lokaal gevorderde, gemetastaseerde en/of niet-reseceerbare PDGFR-negatieve gastro-intestinale stromale tumor bij volwassenen en ouderen zonder succinaat dehydrogenasedeficiëntie en die eerder alleen met imatinib zijn behandeld, behandeling in combinatie met sunitinib.
Manufacturer Cogent
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2025
Expected Registration November 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Primary completion (estimated): 1 juli 2025.

Therapeutic value

Current treatment options Eerste lijn: imatinib. Tweede lijn: sunitinib.
Therapeutic value No estimate possible yet
Substantiation De studie loopt tot 2025 waarvan de eerste resultaten in 2026 bekend zullen zijn.
References NCT05208047 (PEAK)

Expected patient volume per year

Patient volume

< 40

Market share is generally not included unless otherwise stated.
References NKR2024 (1).
Additional remarks In 2023 werden er in Nederland 40 mensen (15 jaar en ouder) gediagnosticeerd met gastro-intestinale stromale tumor (GIST), stadium IV (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.