Nivolumab/relatlimab/hyaluronidase Ph20 Medicine 04 June 2024 Extended indication Extension of indication to include patients with tumour cell PD-L1 expression ≥ 1% in the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Nivolumab/relatlimab/hyaluronidase Ph20 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Extension of indication to include patients with tumour cell PD-L1 expression ≥ 1% in the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Current proprietary name Already available biosimilars / generics Proprietary name Opdualag Manufacturer BMS Portfolio holder BMS 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 Particularity New therapeutical formulation ATMP Submission date Expected Registration Orphan drug Registration phase No registration expected Reimbursement Medicine sluice Broadly excluded Additional remarks De klinische ontwikkelingen zijn stopgezet. 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 (RELATIVITY-127) 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks