Relugolix

Active substance
Relugolix
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Prostate cancer
Extended indication
Advanced Prostate Cancer

1. Product

Manufacturer
Myovant
Mechanism of action
Receptor antagonist
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
GNRH antagonist

2. 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

3. Therapeutic value

Current treatment options
gosereline en leuproreline
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
120 mg
References
NCT03085095

4. Expected patient volume per year

Patient volume

< 2,300

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.