Extended indication Durvalumab in combinatie met tremelimumab als eerste lijnsbehandeling bij unresectable HCC.
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Tremelimumab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Liver cancer
Extended indication Durvalumab in combinatie met tremelimumab als eerste lijnsbehandeling bij unresectable HCC.
Manufacturer AstraZeneca
Mechanism of action CTLA-4 antibody
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 January 2022
Expected Registration February 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Immunotherapie en doelgerichte therapie
Therapeutic value Possible equal value
Substantiation Er wordt verwacht dat deze behandeling mogelijk standaardzorg zal worden en de markt verdeeld zal worden over deze therapie en de atezolizumab/bevacizumab combinatie therapie.
References NCT03298451
Additional comments Behandelduur tot progressie.

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.

References NKR
Additional comments NKR 2016: 158 patiënten met HCC stadium 4. De werkgroep verwacht dat er substitutie plaats zal vinden en hiervan 50-75 patiënten voor deze behandeling in aanmerking komen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

Additional comments Nog niet bepaald.

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.