Nivolumab/hyaluronidase Ph20 Medicine 03 December 2024 Extended indication For information on the full indications for Opdivo solution for injection please refer to the EMA website: https://www.ema.europa.eu/en/medicines/human/variation/opdivo-4 Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Nivolumab/hyaluronidase Ph20 Domain Oncology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication For information on the full indications for Opdivo solution for injection please refer to the EMA website: https://www.ema.europa.eu/en/medicines/human/variation/opdivo-4 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BMS Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Subcutaneous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Nieuwe subcutane toedieningsvorm van nivolumab met recombinant humaan hyaluronidase (rHuPH20). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date June 2024 Expected Registration September 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Is in juni 2024 bij EMA ingediend als Extension Application. Positieve CHMP opinie op 27 maart 2025. https://www.ema.europa.eu/en/medicines/human/variation/opdivo-4 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De volledige resultaten zijn nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References NCT04810078 (CheckMate-67T) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2024 (1). Additional remarks In 2022 werden er 929 diagnoses niercelcarcinoom stadium III en IV gesteld (1). 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks