Dordaviprone Medicine 03 December 2024 Extended indication Dordaviprone monotherapy for treatment of newly diagnosed H3 K27M-mutant diffuse glioma in children, adolescents, adults and elderly following completion of radiotherapy Therapeutic value No estimate possible yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Chimerix Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2025 Expected Registration October 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie aan de hand van IHSI-inschatting. Therapeutic value Current treatment options Bestraling Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment 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. Maximum patient volume for sluice 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks