Extended indication Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresect
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
Proprietary name Imfinzi
Manufacturer AstraZeneca
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
Submission date 2023
Expected Registration December 2023
Registration phase Positive CHMP opinion
Additional remarks Posititve CHMP-opinie oktober 2023

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.