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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
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
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). 3.598 (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.