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Dordaviprone

Extended indication Dordaviprone monotherapy for treatment of newly diagnosed H3 K27M-mutant diffuse glioma in children,
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Dordaviprone
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Brain cancer
Extended indication Dordaviprone monotherapy for treatment of newly diagnosed H3 K27M-mutant diffuse glioma in children, adolescents, adults and elderly following completion of radiotherapy
Manufacturer Chimerix
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 September 2025
Expected Registration October 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie aan de hand van IHSI-inschatting.

Therapeutic value

Current treatment options Bestraling
Therapeutic value No estimate possible yet
Frequency of administration 1 times every 2 weeks
Dosage per administration 625 mg
References NCT05580562 (ACTION)
Additional remarks Patiënten ≥52.5 kg: 625 mg eenmaal per een of twee weken. Patiënten <52.5 kg: een dosering (en bijbehorende aantal capsules) aangepast aan lichaamsgewicht en afgerond tot incrementen van 125 mg.

Expected patient volume per year

Patient volume

8 - 10

Market share is generally not included unless otherwise stated.
References El-Khouly. PhD-Thesis Vrije Universiteit Amsterdam. 2022 (1)
Additional remarks Jaarlijks krijgen 8 tot 10 kinderen in Nederland de diagnose diffuus intrinsiek ponsglioom (DIPG) (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.