Resminostat Medicine 03 June 2025 Extended indication Resminostat monotherapy for maintenance treatment of advanced (stage IIB-IVB) mycosis fungoides/Sezary syndrome in adults and elderly who have achieved disease control with prior systemic therapy. Therapeutic value No estimate possible yet Total cost Registration phase Negative CHMP opinion Product Active substance Resminostat Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Resminostat monotherapy for maintenance treatment of advanced (stage IIB-IVB) mycosis fungoides/Sezary syndrome in adults and elderly who have achieved disease control with prior systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Kinselby Manufacturer 4sc Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Histon-deacetylaseremmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2024 Expected Registration Orphan drug Yes Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve CHMP-opinie in mei 2025. 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 5 times every 2 weeks Dosage per administration 3 x 200mg References NCT02953301 (RESMAIN) Additional remarks 3 x 200mg tabletten oraal, 5 dagen behandeling gevolgd door 9 dagen rust (herhaalt als cyclus tot vooruitgang of onaanvaardbare toxiciteit). Expected patient volume per year Patient volume < 15 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks In 2021 waren er 15 diagnoses huidlymfoom, stadium II t/m IV. Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke kosten in Nederland. 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