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 Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tucidinostat (HBI-8000) is a benzamide histone deacetylase inhibitors (HDACIs) that alters histone structure to control the expression of many genes necessary to the growth of cancer cells. In addition, the drug also controls the nuclear transport of a key protein involved in tumor immunity and the tumor microenvironment, modulates the tumor microenvironment, and alters innate and adaptive immunity, leading to increased cancer cell death. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date September 2025 Expected Registration October 2026 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 30 mg oral BIW + nivolumab IV at specific doses on specific days 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 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