Extended indication Advanced Prostate Cancer.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Relugolix
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Advanced Prostate Cancer.
Manufacturer Myovant
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments GNRH antagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Gosereline en leuproreline.
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 120 mg
References NCT03085095.

Expected patient volume per year

Additional comments Een relatief grote groep personen zou mogelijk in aanmerking kunnen komen voor deze behandeling. Het is echter nog lastig om een goede inschatting van het aantal te patiënten dat realistisch gezien in aanmerking komt.

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

Indication extension Yes
Indication extensions Uterine fibroids, endometriosis-related pain.
References Clinicaltrials.gov.

Other information

There is currently no futher information available.