Extended indication Extension of indication to include in combination with platinum -containing chemotherapy the treatment of adult patients with mismatch repair deficien
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Dostarlimab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Ovarian cancer
Extended indication Extension of indication to include in combination with platinum -containing chemotherapy the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability -high (MSI -H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy
Proprietary name Jemperli
Manufacturer GSK
Portfolio holder GSK
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date December 2023
Expected Registration October 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information