Belzutifan Medicine 04 December 2025 Extended indication Belzutifan in combination with pembrolizumab as adjuvant treatment of clear cell renal cell carcinoma Therapeutic value Total cost Registration phase Clinical trials Product Active substance Belzutifan Domain Oncology Reason of inclusion Indication extension IND Main indication Extended indication Belzutifan in combination with pembrolizumab as adjuvant treatment of clear cell 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 2026 Expected Registration November 2026 Orphan drug Registration phase Clinical trials 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 NCT05239728