Extended indication Serous epithelial ovarian, fallopian tube or primary peritoneal cancer with BRCA1 mutation, stage II
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Veliparib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Ovarian cancer
Extended indication Serous epithelial ovarian, fallopian tube or primary peritoneal cancer with BRCA1 mutation, stage III or IV high-grade - first-line with carboplatin and paclitaxel.
Manufacturer Abbvie
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks PARP-remmer

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 66

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks Hoog stadium (FIGO III en IV) ovariumcarcinoom, hooggradig sereus, behandeld met o.a. chemotherapie in de eerste lijn. Selectie uit NKR: 1.316 patiënten over in 2014 en 2015 (dus per jaar 658). Schatting: 10% BRCA1 in de populatie (gebaseerd op de literatuur en praktijk).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.