Nemvaleukin alfa Medicine 03 December 2024 Extended indication Nemvaleukin alfa monotherapy for second line treatment of unresectable and/or metastatic mucosal melanoma in adults and elderly who have previously received anti-PD-L1 therapy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nemvaleukin alfa Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Nemvaleukin alfa monotherapy for second line treatment of unresectable and/or metastatic mucosal melanoma in adults and elderly who have previously received anti-PD-L1 therapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Mural Oncology Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Er is nog geen huidige behandeling. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de ARTISTRY-6 studie nog. De resultaten dienen afgewacht te worden. Aangezien er nog geen behandeling is zou het mogelijk wel een aanwinst kunnen zijn. Duration of treatment Frequency of administration Dosage per administration References NCT04830124 (ARTISTRY-6) Additional remarks Expected patient volume per year Patient volume < 110 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); MedNet (2). Additional remarks In 2022 waren er ongeveer 1.100 diagnoses melanoom, stadium III en IV (1). De incidentie van mucosale melanomen, is ongeveer 1% van alle gevallen van melanoom (2). Het patiëntvolume is afhankelijk van het aantal gebruikers van anti-PD-L1 therapie binnen deze groep. 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