Darolutamide

Active substance Darolutamide
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Prostate cancer
Extended indication Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Product

Proprietary name Nubeqa
Manufacturer Bayer
Mechanism of action Antiandrogen
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)
Additional comments Androgreenreceptor blokker.

Registration

Registration route Centralised (EMA)
Submission date March 2019
Expected Registration March 2020
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in januari 2020

Therapeutic value

Current treatment options Enzalutamide en apalutamide zijn geregistreerd voor deze indicatie.
Therapeutic value No judgement
Substantiation Metastasevrije overleving was significant langer in vergelijking met placebo. De verwachting is dat de therapeutische waarde vergelijkbaar is met met enzalutamide en apalutamide.
Duration of treatment Median 14.8 month / months
Frequency of administration 2 times a day
Dosage per administration 600 mg
References NCT02200614; Fizazi et al. N Engl J Med. 2019 Mar 28;380(13):1235-1246
Additional comments Studieresultaten van de ARASENS studie verwacht in Q4/2020.

Expected patient volume per year

Patient volume

53

Market share is generally not included unless otherwise stated.

References NKR; Kanker.nl; Fabrikant
Additional comments In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Darolutamide zal binnen deze indicatie moeten moeten concurreren met apalutamide en enzalutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53).

Expected cost per patient per year

Cost 30,000 - 40,000
References Medicijnkosten.nl
Additional comments Moet concurreren met enzolutamide en apalutamide dus de prijs zal vergelijkbaar zijn.

Potential total cost per year

Total cost

1,855,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Metastatic castration sensitive cancer.
References NCT02799602
Additional comments Deze indicatieuitbreiding wordt pas na 2023 verwacht.

Other information

There is currently no futher information available.