Tucidinostat

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
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.
Manufacturer	Adooq
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
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)
ATMP	No
Submission date	March 2025
Expected Registration	April 2026
Orphan drug	Yes
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No estimate possible yet
Dosage per administration	30 mg
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.
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.)

Patient volume

< 775

Market share is generally not included unless otherwise stated.

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

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.