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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.