Azenosertib Medicine 04 December 2025 Extended indication Azenosertib monotherapy for second line or later treatment of platinum-resistant high-grade serous Fallopian tube cancer, Ovarian cancer, Primary peritoneal carcinosarcoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Azenosertib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Ovarian cancer Extended indication Azenosertib monotherapy for second line or later treatment of platinum-resistant high-grade serous Fallopian tube cancer, Ovarian cancer, Primary peritoneal carcinosarcoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Zentalis Portfolio holder Zentalis Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options De huidige standaard voor platinum-resistente patiënten bestaat uit non-platinum chemotherapie, met mogelijke winst van combinatietherapieën zoals bevaziciumab plus gemcitabine Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op de datum van data cutoff op 2 december 2024 bedroeg de ORR onder de intention-to-treat (ITT)-populatie met cycline E1-positieve tumoren (n = 48) 31,3% (95% BI, 18,7%-46,3%). De mediane responsduur (DOR) was nog niet volledig bekend en bedroeg ongeveer 5,5 maanden (95% BI, 2,7-niet evalueerbaar). Deze resultaten voldoen voorlopig nog niet aan de PASKWIL-criteria. Duration of treatment Frequency of administration Dosage per administration References NCT05128825 (DENALI); Targeted Oncology. feb. 2025; Expertopinie Additional remarks Expected patient volume per year Patient volume < 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2024 (1); Expertopinie (2) Additional remarks In Nederland worden jaarlijks ongeveer 1.300 nieuwe gevallen van hooggradige serieuze ovarium-, tuba- en primaire peritoneale carcinosarcoom vastgesteld (1). Van deze patiënten is een deel platinum-resistent, waarbij slechts een deel geschikt is voor tweedelijns of latere behandeling met geneesmiddelen zoals azenosertib. Het potentiële patiëntvolume voor azenosertib wordt geschat op minder dan 300 patiënten per jaar in Nederland (2). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks