Nofazinlimab

Extended indication	Nofazinlimab in combination with lenvatinib for first line treatment of unresectable advanced hepatocellular carcinoma in adults and elderly who are ineligible for surgery and/or locoregional therapy
Therapeutic value	No estimate possible yet
Total cost	7,500,000.00
Registration phase	Clinical trials

Product

Active substance	Nofazinlimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Liver cancer
Extended indication	Nofazinlimab in combination with lenvatinib for first line treatment of unresectable advanced hepatocellular carcinoma in adults and elderly who are ineligible for surgery and/or locoregional therapy
Manufacturer	CStone
Mechanism of action	PD-1 / PD-L1 inhibitor
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	September 2025
Expected Registration	October 2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Gebaseerd op een primary completion datum in juni 2025 kan een indieningsdatum in september 2025 en een verwachte registratie in oktober 2026 geschat worden.

Therapeutic value

Current treatment options	Atezolizumab en bevacizumab, tremelimumab en durvalumab of TKI-remmers.
Therapeutic value	No estimate possible yet
Substantiation	Er zijn al relatief veel verschillende behandelopties in de eerste lijn van deze indicatie. Er is daarnaast geen head-to-head studie om een mogelijke meerwaarde mee aan te tonen ten opzichte van deze producten.
References	NCT04194775 (CS1003-305)

Expected patient volume per year

Patient volume	< 150 Market share is generally not included unless otherwise stated.
References	NKR 2021 (1).
Additional remarks	In 2021 waren er 787 diagnoses hepatocellulair carcinoom, waarvan 200 in stadium IV (1). Er wordt op basis van een expert opinie verwacht dat er uiteindelijk maximaal 150 patiënten in aanmerking zullen komen.

Patient volume

< 150

Market share is generally not included unless otherwise stated.

References

NKR 2021 (1).

Additional remarks

In 2021 waren er 787 diagnoses hepatocellulair carcinoom, waarvan 200 in stadium IV (1). Er wordt op basis van een expert opinie verwacht dat er uiteindelijk maximaal 150 patiënten in aanmerking zullen komen.

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
Additional remarks	Prijs in lijn verwacht met andere PD-1(L)-receptor antagonisten.

Potential total cost per year

Total cost	7,500,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Total cost

7,500,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.