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.