Pembrolizumab Medicine 04 December 2025 Extended indication Adjuvant pembrolizumab in patients with hepatocellular carcinoma (HCC) and complete radiologic response after surgical resection or local ablation. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Adjuvant pembrolizumab in patients with hepatocellular carcinoma (HCC) and complete radiologic response after surgical resection or local ablation. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Out of the sluice Additional remarks De fase III-studie KEYNOTE-937 is stopgezet, nadat een tussentijdse analyse liet zien dat adjuvante pembrolizumab bij HCC geen voordeel bood ten opzichte van placebo voor recidiefvrije overleving. 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 Duration of treatment Frequency of administration Dosage per administration References NCT03867084 (KEYNOTE-937) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Voor alle indicatie-uitbreidingen van pembrolizumab is een financieel arrangement afgesproken tot 1 januari 2027. 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