Relatlimab Medicine 08 December 2020 Extended indication Patients With Previously Untreated Metastatic or Unresectable Melanoma in combination with nivolumab. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Relatlimab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Patients With Previously Untreated Metastatic or Unresectable Melanoma in combination with nivolumab. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BMS Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antibody-dependent cell cytotoxicity; T lymphocyte stimulant. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2021 Expected Registration October 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in het vierde kwartaal van 2022. Therapeutic value Current treatment options Pembrolizumab, nivolumab, ipilimumab, dabrafenib/trametinib, encorafenib/binimetinib, vemurafenib/cobimetinib. 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 NCT03470922 Additional remarks Expected patient volume per year Patient volume < 80 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Melanoom van de huid betreft 6.729 patiënten in 2018, hiervan zijn er 541 patiënten met stadium 3 en 203 patiënten met stadium 4 (maximaal 744 patiënten die in aanmerking komen voor deze behandeling.) Hiervan zijn zo'n 80 patiënten behandeld met nivolumab, dit lijkt de meest waarschijnlijke groep waar dit middel ingezet gaat worden. 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 Yes Indication extensions Acute myeloid leukaemia; Colorectal cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Renal cell carcinoma; Soft tissue sarcoma; Solid tumours. References Adisinsight. Additional remarks Fase 2 studies Other information Additional remarks