Cretostimogene grenadenorepvec Medicine 04 December 2025 Extended indication Cretostimogene grenadenorepvec monotherapy for the treatment of adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer, including patients with carcinoma in situ (with or without Ta or T1 papillary tumors) and those with high-grade Ta or T1 papillary disease without carcinoma in situ. Therapeutic value Possible added value Total cost € 109,375,000.00 Registration phase Clinical trials Product Active substance Cretostimogene grenadenorepvec Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Cretostimogene grenadenorepvec monotherapy for the treatment of adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer, including patients with carcinoma in situ (with or without Ta or T1 papillary tumors) and those with high-grade Ta or T1 papillary disease without carcinoma in situ. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer CG oncology Portfolio holder CG oncology Mechanism of action Route of administration Intravesical Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Yes Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Radicale cystectomie, chemohyperthermie (HIVEC®) als blaassparend alternatief, off-label intravesicale chemotherapie (gemcitabine/docetaxel), en in studieverband of beperkt off-label immunotherapie zoals pembrolizumab. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Cretostimogene grenadenorepvec biedt overtuigende complete responspercentages (74,5%) met duurzame responsen: de mediane responsduur werd niet bereikt, maar bedraagt meer dan 27 maanden; 64% van de responders behoudt zijn respons na 12 maanden. Deze resultaten lijken de PASKWIL-criteria te halen. Duration of treatment Frequency of administration 1 times a week Dosage per administration References NCT04452591 (BOND-003); Topline results from BOND-003. CG Oncology. 2024; Expertopinie 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-spierinvasieve 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 € 150,000.00 - 200,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References ICER; Drugs.com Additional remarks Er is nog geen marktprijs beschikbaar. Een vergelijkbare behandeling nadofaragene firadenovec (Adstiladrin) kost in de Verenigde Staten ongeveer $240.000 per jaar. Schatting cretostimogene grenadenorepvec: €150.000 tot €200.000 per jaar. Potential total cost per year Total cost € 109,375,000.00 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