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Niraparib

Zejula

Extended indication

Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with meta

Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

Niraparib
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer
Proprietary name

Zejula
Manufacturer

Janssen
Mechanism of action

PARP inhibitor

Registration

Type of trajectory

Normal trajectory
ATMP

No
Submission date

2024
Expected Registration

2025
Registration phase

Clinical trials
Additional remarks 
NCT03748641

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

Mediane rPFS in de BRCA1/2 subgroep was significant langer in de niraparib + AAP groep vergeleken met de placebo + AAP groep (16,6 versus 10,9 maanden; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001). Er wordt verwacht dat niraparib niet bij de gehele HHR populatie ingezet zal gaan worden, maar enkel bij patiënten met de BRCA1/2 mutatie.
References 
NCT03748641

Expected patient volume per year

Patient volume

< 220

Market share is generally not included unless otherwise stated.
References 
(1) IKNL 2022; (2) https://iknl.nl/kankersoorten/prostaatkanker/registratie/incidentie
Additional remarks 
In 2022 waren er 12.400 patiënten met prostaatkanker (1). 3598
 (2). Het betreft hier 2.197 patiënten die zich in stadium 4 bevonden. Daarvan heeft ongeveer 10% een BRCA1/2 mutatie.

Expected cost per patient per year

References 
G-standaard
Additional remarks 
Een capsule van 100mg kost €111,45

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.