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Pembrolizumab

Medicine

Extended indication Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) me
Therapeutic value Possible added value for a subgroup
Total cost € 0.00
Registration phase Positive CHMP opinion

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Skin cancer
Extended indication Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection.
Proprietary name Keytruda
Manufacturer MSD
Portfolio holder MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
ATMP No
Submission date December 2025
Expected Registration July 2026
Orphan drug No
Registration phase Positive CHMP opinion
Medicine sluice Out of the sluice
Additional remarks Positieve CHMP-opinie in mei 2026.

Therapeutic value

Current treatment options Intraveneuze pembrolizumab
Therapeutic value Possible added value for a subgroup

This assessment does not indicate any potential inclusion in the package.
Substantiation In de klinische studie is de subcutane variant vergeleken met de intraveneuze variant. De ORR was 45% (95% CI: 39, 52) in de subcutane Keytruda arm en 42% (95% CI: 33, 51) in de intraveneuze pembrolizumab arm. Er waren geen verschillen te vinden in PFS of OS. Een vraag die ook meespeelt is wat de voordelen en nadelen zijn van minder dagbehandelingen. Het biedt extra comfort en gemak voor patiënten, maar niet per se een effectievere behandeling.
References NCT03665597

Expected patient volume per year

Patient volume 441

Market share is generally not included unless otherwise stated.
References 1: Gipdatabank;
Additional remarks Het aantal patiënten met een melanoom advanced metastatic of inoperabel dat behandeld werd met intraveneuze pembrolizumab lag in 2024 op 441 patiënten (1).

Expected cost per patient per year

Cost € < 0.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.
Additional remarks Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. AIP per juni 2026: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost € 0.00

Off label use

Indication extension

Other information