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Pembrolizumab

Keytruda

Extended indication

Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with

Therapeutic value

Possibly no place in the treatment regimen
Registration phase

Registration application pending

Product

Active substance

Pembrolizumab
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Lung cancer
Extended indication

Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with Stage IB (T2a ≥ 4 cm), II or IIIA non-small cell lung carcinoma (NSCLC) who have undergone complete resection.
Proprietary name

Keytruda
Manufacturer

MSD
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

April 2022
Expected Registration

February 2023
Orphan drug

No
Registration phase

Registration application pending

Therapeutic value

Therapeutic value

Possibly no place in the treatment regimen
Substantiation

De verwachting is dat op basis van de resultaten uit de studie de paskwil criteria niet gehaald zullen worden.

Expected patient volume per year

References 
NKR; Longkanker Nederland factsheet 2019; Heineman et al. 2016; DICA jaarrapportage - DLSA 2015; PALGA/IKNL. Pakketadvies ADAURA: ZIN Pakketadvies osimertinib (Tagrisso®) bij niet-kleincellige longkanker (NSCLC) 2021.
Additional remarks 
In 2019 waren er 9.929 patiënten met niet-kleincellig longcarcinoom (NKR 2019), waarvan 19%, 8%, en 11% met pathologisch stadium I, II, en IIIA (Longkanker Nederland factsheet 2019). Totaal ondergaan 1.193 patiënten in stadium IB-IIIA een resectie (NKR 2017, Heineman et al. 2016). 90% van de resecties in Nederland is een R0 resectie (1.073 patiënten) (DICA jaarrapportage - DLSA 2015).

Expected cost per patient per year

Cost

< 90,000.00
References 
G-Standaard
Additional remarks 
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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.