Abexinostat

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
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. Er loopt een fase 3 studie (NCT03592472) die eind 2024 sluit qua inclusie.
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.
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).

Patient volume

< 663

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. 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

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.