Tucidinostat Medicine 04 June 2024 Extended indication Tucidinostat in combination with nivolumab for first line, second line treatment of unresectable or metastatic Melanoma in adolescents, adults and elderly who were not previously treated with PD-1 or PD-L1 inhibitors. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tucidinostat Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Tucidinostat in combination with nivolumab for first line, second line treatment of unresectable or metastatic Melanoma in adolescents, adults and elderly who were not previously treated with PD-1 or PD-L1 inhibitors. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Adooq Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tucidinostat (HBI-8000) is een benzamide histondeacetylaseremmer (HDACI) die de histon-structuur verandert om de expressie van veel genen te reguleren die nodig zijn voor de groei van kankercellen. Daarnaast reguleert het medicijn ook het nucleaire transport van een belangrijk eiwit dat betrokken is bij de tumorimmuniteit en de tumormicro-omgeving, moduleert het de tumormicro-omgeving en verandert het de aangeboren en adaptieve immuniteit, wat leidt tot een verhoogde kans op kankerceldood. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date October 2026 Expected Registration November 2027 Orphan drug Yes 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 30mg References NCT04674683 Additional remarks HBI-8000 30mg oraal BIW plus nivolumab intraveneus in specifieke doses op specifieke dagen. Expected patient volume per year Patient volume < 775 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020; Additional remarks Melanoom van de huid betreft 6.746 patiënten in 2020, hiervan zijn er 687 patiënten met stadium 3 en 88 patiënten met stadium 4 (maximaal 775 patiënten die in aanmerking komen voor deze behandeling.) Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. 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