Pembrolizumab Medicine 04 December 2025 Extended indication Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Extended indication Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder MSD Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2025 Expected Registration December 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Out of the sluice Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement tot 1 januari 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Pembrolizumab is in de eerste lijn geregistreerd voor endometriumcarcinoom, zowel pMMR als dMMR maar dan wel met chemotherapie. Het is niet duidelijk wat de rol van monotherapie is. Er zijn op dit moment nog geen resultaten bekend. Duration of treatment Maximal 2 year / years Frequency of administration 1 times every 3 weeks Dosage per administration 200mg intraveneus elke drie weken (of 400mg elke zes weken) References NCT05173987 ;NCT02715284 Additional remarks Expected patient volume per year Patient volume 280 - 430 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2023 Additional remarks In Nederland krijgen jaarlijks ongeveer 1.400 vrouwen endometriumcarcinoom, waarvan 20 tot 30% een deficiënt mismatch repair (dMMR) tumor heeft. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks