Nivolumab/relatlimab/hyaluronidase Ph20 Medicine 04 June 2024 Extended indication Patients with previously untreated metastatic or unresectable melanoma. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nivolumab/relatlimab/hyaluronidase Ph20 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Patients with previously untreated metastatic or unresectable melanoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BMS Portfolio holder Mechanism of action Immunostimulation Route of administration Subcutaneous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 NCT05625399 Additional remarks Het betreft een non-inferiority fase 1 studie. Er zijn nog geen resultaten bekend. De verwachting is dat de intraveneuze en subcutane toediening bio-equivalent zijn. Expected patient volume per year Patient volume < 775 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; expertopinie Additional remarks Melanoom van de huid betreft 6.746 patiënten in 2020, hiervan zijn 687 patiënten met stadium 3 en 88 patiënten met stadium 4 (maximaal 775 patiënten die in aanmerking komen voor deze behandeling.) Het patiënten aantal is ook afhankelijk van de rol die nivolumab/relatlimab gaat krijgen. 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