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 Registration phase 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 Route of administration Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date January 2026 Expected Registration August 2027 Orphan drug Registration phase Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References 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 Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Indication extensions Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks NCT04736706