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Pembrolizumab

Keytruda

Extended indication Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and ga
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Proprietary name Keytruda
Manufacturer MSD
Portfolio holder MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2023
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment Maximal 1 year / years
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional remarks Uitgaande van de AIP en de injectieflacon 25mg/ml, flacon 4ml (oplossing) en een behandeling van 1x per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

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

Indication extension Yes
Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.

Other information

There is currently no futher information available.