Version 2

Pembrolizumab

Medicine

Extended indication Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epitheli
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Oncology other
Extended indication Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date May 2024
Expected Registration January 2025
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie november 2024.

Therapeutic value

Current treatment options Nivolumab in combinatie met ipilimumab in de eerste lijn.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Met een follow-up van 16,2 maanden (IQR 8,3-27,8), was de totale overleving significant langer met pembrolizumab (mediane totale overleving 17,3 maanden [95% CI 14,4-21,3] met pembrolizumab versus 16,1 maanden [13,1 tot 18,2] met chemotherapie alleen, hazard ratio voor overlijden 0,79. De PASKWIL criteria worden niet gehaald.
References NCT02784171 (KEYNOTE-483)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References IKNL. 2022.
Additional remarks Mesothelioom is zeldzaam. In Nederland is de jaarlijkse incidentie ongeveer 600.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information