Nogapendekin alfa inbakicept Medicine 04 June 2026 Extended indication Nogapendekin alfa inbakicept in combination with bacillus calmette-guerin for second line treatment of BCG-unresponsive, high-grade Ta/T1 disease non-muscle invasive bladder cancer in adults and elderly. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Nogapendekin alfa inbakicept Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Nogapendekin alfa inbakicept in combination with bacillus calmette-guerin for second line treatment of BCG-unresponsive, high-grade Ta/T1 disease non-muscle invasive bladder cancer in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Anktiva Manufacturer ImmunityBio Portfolio holder ImmunityBio Mechanism of action Route of administration Intravesical Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Interleukineagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date June 2026 Expected Registration January 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Radicale cystectomie Therapeutic value Substantiation Er zijn nog geen resultaten bekend. Het zal in een aantal gevallen een alternatief kunnen worden voor operatie (bij bijvoorbeeld oudere patiënten, multi morbiditeit). Duration of treatment Frequency of administration Dosage per administration References NCT03022825 (QUILT-3.032) Additional remarks Expected patient volume per year Patient volume 450 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Babjuk et al. 2024 (1); NKR 2023 (2); Kamat et al. 2014 (3) Additional remarks Jaarlijks krijgen ongeveer 6.500 mensen in Nederland blaaskanker, waarvan circa 5.000 patiënten een niet-spier invasieve vorm (NMIBC) hebben (IKNL, 2023). Van deze groep worden ongeveer 1.500 tot 2.000 patiënten behandeld met BCG vanwege hooggradige Ta/T1-laesies of carcinoma in situ (CIS) (1,2). Naar schatting wordt 30 tot 40% BCG-ongevoelig, wat neerkomt op 450 tot 800 patiënten per jaar (3) 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