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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.