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Vorasidenib

Voranigo

Extended indication Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing astrocytoma or
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Vorasidenib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Brain cancer
Extended indication Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) R132 mutation or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients 12 years and older following surgical intervention.
Proprietary name Voranigo
Manufacturer Servier
Portfolio holder Servier
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
ATMP No
Submission date January 2024
Expected Registration November 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Watch-and-wait
Therapeutic value Possible added value
Substantiation De PFS was significant beter in de vorasidenib groep vergeleken met de placebo groep (mediane progressie-vrije overleving, 27,7 maanden versus 11,1 maanden; hazard ratio voor ziekteprogressie of overlijden, 0.39; 95% confidence interval [CI], 0.27 to 0.56; P<0.001).
Frequency of administration 1 times a day
Dosage per administration 40 mg
References https://www.nejm.org/doi/full/10.1056/NEJMoa2304194

Expected patient volume per year

Patient volume

200 - 250

Market share is generally not included unless otherwise stated.
References IKNL, expertopinie (1)
Additional remarks Patientvolume tussen 200 en 250 gebaseerd op incidentie astrocytoom en oligodendroglioom en uiteindelijke verwachte indicatie (IKNL en expert opinion).

Expected cost per patient per year

Additional remarks Er is nog geen prijs bekend.

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.