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Durvalumab

Imfinzi

Extended indication monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
Proprietary name Imfinzi
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intracavernous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks https://www.ema.europa.eu/en/medicines/human/variation/imfinzi-0 DUO-E studie Durvalumab in combinatie met olaparib heeft CHMP opinie voor de pMMR groep

Registration

Registration route Decentralised
Type of trajectory Normal trajectory
ATMP No
Submission date November 2023
Expected Registration September 2024
Orphan drug No
Registration phase Registered
Additional remarks CHMP opinie juli 2024

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.