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Abexinostat

Extended indication Abexinostat in combination with pazopanib for first line, second line treatment of locally advanced
Therapeutic value No estimate possible yet
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.
Manufacturer Xynomic
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date March 2025
Expected Registration April 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Fast track FDA

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase 1b studie ziet er veelbelovend uit. Echter zijn er nog nog geen resultaten uit de fase 3 studie bekend.
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

< 995

Market share is generally not included unless otherwise stated.
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.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.