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Relugolix

Extended indication Advanced Prostate Cancer
Therapeutic value No judgement
Registration phase Registration application pending

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 Intermural (MSZ)
Additional remarks GNRH antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2020
Expected Registration May 2021
Orphan drug No
Registration phase Registration application pending

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

Patient volume

< 2,300

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2016. Deze gehele groep personen zou mogelijk in aanmerking kunnen komen. Afhankelijk van de prijs en therapeutische waarde zal een deel van deze patiënten het middel mogelijk gaan ontvangen.

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.