Abexinostat Medicine 04 June 2024 Extended indication Abexinostat in combination with pazopanib for first line, second line treatment of locally advanced unresectable or metastatic Clear cell renal cell carcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Abexinostat Domain Oncology Reason of inclusion New medicine (specialité) Main indication Kidney cancer Extended indication Abexinostat in combination with pazopanib for first line, second line treatment of locally advanced unresectable or metastatic Clear cell renal cell carcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Xynomic Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fast track FDA Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 1b studie ziet er veelbelovend uit. Echter zijn er nog nog geen resultaten uit de fase 3 studie bekend. Er loopt een fase 3 studie (NCT03592472) die eind 2024 sluit qua inclusie. Duration of treatment Frequency of administration Dosage per administration 80 mg References NCT03592472 (Phase 3) Additional remarks The starting dose and schedule of abexinostat will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of abexinostat should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them. Expected patient volume per year Patient volume < 663 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks In 2021 werden er 411 diagnoses niercelcarcinoom stadium III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV. De werkgroep schat in dat ongeveer twee derde van deze patiënten in aanmerking komt (afhankelijk van de uitkomsten van de studie). 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