Extended indication Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
Therapeutic value Possible equal value
Total cost 18,700,000.00
Registration phase Registration application pending

Product

Active substance Senaparib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Ovarian cancer
Extended indication Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
Manufacturer IMPACT
Mechanism of action PARP inhibitor
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2025
Expected Registration September 2026
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Andere PARP-remmers
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.

Substantiation De eerste studie is positief op progression-free survival (PFS). Er is nog geen overall survival (OS) data. Mogelijk zal het vergelijkbaar zijn ten opzichte van andere PARP-remmers.
Frequency of administration 1 times a day
Dosage per administration 100 mg
References NCT04169997 (FLAMES)

Expected patient volume per year

Patient volume 374

Market share is generally not included unless otherwise stated.

References 1: IKNL2022;
Additional remarks In 2022 waren er volgens IKNL 374 diagnoses van epitheliaal ovariumcarcinoom stadium IV (1).

Expected cost per patient per year

Cost < 50,000.00

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.

Additional remarks Op basis van vergelijkbare PARP-remmers

Potential total cost per year

Total cost 18,700,000.00

Off label use

Indication extension

Other information