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.