Extended indication Olvimulogene nanivacirepvec in combination with platinum-doublet chemotherapy and bevacizumab for fourth line or later treatment of platinum-resistant
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Olvimulogene nanivacirepvec
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Ovarian cancer
Extended indication Olvimulogene nanivacirepvec in combination with platinum-doublet chemotherapy and bevacizumab for fourth line or later treatment of platinum-resistant/refractory, high-grade serous, non-resectable Fallopian tube cancer, Ovarian cancer, Primary peritoneal carcinosarcoma in adults and elderly.
Manufacturer Genelux
Portfolio holder Genelux
Route of administration Intraperitoneal
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date June 2026
Expected Registration July 2027
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Non-platinum monotherapie, eventueel in combinatie met bevacizumab.
Therapeutic value No estimate possible yet

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

Substantiation De studie includeert nog tot september 2025. Er zijn nog geen resultaten beschikbaar.
References NCT05281471 (OnPrime, GOG-3076)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References IKNL 2024 (1)
Additional remarks In Nederland worden jaarlijks ongeveer 1.300 nieuwe gevallen van hooggradige serieuze ovarium-, tuba- en primaire peritoneale carcinosarcoom vastgesteld (1). Hiervan is een deel platinum-resistent, waarbij slechts een klein deel geschikt is voor een vierdelijns of latere behandeling.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information