Extended indication Indicated for the identification of prostate specific membrane antigen (PSMA)-positive lesions after
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Gozetotide
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Indicated for the identification of prostate specific membrane antigen (PSMA)-positive lesions after radiolabelling with gallium-68
Proprietary name Locametz
Manufacturer Telix
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2021
Expected Registration December 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen oktober 2022.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT02940262

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.