Extended indication Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
Therapeutic value Possible equal value
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.
Mechanism of action PARP inhibitor
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: IMPACT

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

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information