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Tremelimumab

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

July 2022
Expected Registration

July 2023
Orphan drug

No
Registration phase

Clinical trials
Additional remarks 
Fabrikant verwacht indiening in juli 2022.

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 remarks 
Behandelduur tot progressie.

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.
References 
NKR
Additional remarks 
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 remarks 
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.