Expand all sections

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 comments 
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.