Pembrolizumab Medicine 04 December 2025 Extended indication Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. Therapeutic value Total cost € 68,978,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder 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 Submission date January 2027 Expected Registration August 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Maximal 2 year / years Frequency of administration 1 times every 6 weeks Dosage per administration 400 mg References NCT04736706 (LITESPARK-012, MK-6482-012) Additional remarks Pembrolizumab 400mg in combinatie met quavonlimab 25mg, toegediend om de zes weken gedurende maximaal 18 toedieningen (tot ongeveer 2 jaar). Expected patient volume per year Patient volume < 758 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Kanker.nl (2). Additional remarks In 2022 waren er 948 diagnoses niercelcarcinoom, stadium 3 en 4 (1). Ongeveer 80% van de gevallen is heldercellige niercelcarcinoom (n=758) (2). Expected cost per patient per year Cost € 91,000.00 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. References medicijnkosten Additional remarks Keytruda 25mg/ml flacon van 4ml is € 2.860,56. Schema: 400 mg elke 6 weken 4 × €2.624,38 = €10.497,52 per kuur (excl. btw). Potential total cost per year Total cost € 68,978,000.00 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 NCT04736706