Bimekizumab

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.
Therapeutic value	No estimate possible yet
Registration phase	Positive CHMP opinion

Product

Active substance	Pembrolizumab
Domain	Oncology
Reason of inclusion	Indication extension
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 route	Centralised (EMA)
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.

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

References	IKNL. 2022.
Additional remarks	Mesothelioom is zeldzaam. In Nederland is de jaarlijkse incidentie ongeveer 600.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.