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Xevinapant

Extended indication Xevinapant in combination with platinum-based chemoradiotherapy is indicated for the treatment of pa
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Xevinapant
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Head and neck cancer
Extended indication Xevinapant in combination with platinum-based chemoradiotherapy is indicated for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
Manufacturer Merck
Portfolio holder Merck
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Liquid
Budgetting framework Intermural (MSZ)
Centre of expertise Hoofd-hals oncologische expertisecentra
Additional remarks Previously known as Debio 1143. Inhibitor of apoptosis proteins (IAP) inhibitor.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemoradiotherapie (CRT)
Therapeutic value No estimate possible yet
Substantiation Eerdere resultaten uit de fase II studie toonden aan dat xevinapant toegevoegd aan standard-of-care CRT een statistisch significant resultaat geven. Indien dezelfde resultaten uit de fase 3 studie komen is er waarschijnlijk een meerwaarde.
Duration of treatment Maximal 21 day / days
Frequency of administration 6 times a year
Dosage per administration 200 mg oraal eenmaal daags van dag 1 t/m 14 van een 21-daagse behandelcyclus gedurende zes cycli, gelijktijdig bij start van op cisplatine gebaseerde chemoradiotherapie (CRT)
References NCT04459715
Additional remarks Totale behandelduur 126 dagen, waarvan 84 dagen met toediening werkzame stof.

Expected patient volume per year

Patient volume

< 1,755

Market share is generally not included unless otherwise stated.
References NKR2021(1);
Additional remarks Hoofd-hals tumoren, stadium 3 en 4, respectievelijk 548 en 1.207. In totaal betekent dit dat er 1.755 patiënten in aanmerking komen. Het gedeelte patiënten dat enkel met chemotherapie behandeld wordt zal ook in aanmerking komen voor xevinapant.

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.