Lutetium (177Lu) zadavotide guraxetan Medicine 03 December 2024 Extended indication Lutetium (177Lu) zadavotide guraxetan monotherapy for second line treatment of metastatic castration-resistant prostate cancer in adults and elderly previously treated with only one previous AR-directed therapy and are taxane-based chemonaive. Therapeutic value No estimate possible yet Total cost € 144,052,650.00 Registration phase Clinical trials Product Active substance Lutetium (177Lu) zadavotide guraxetan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Lutetium (177Lu) zadavotide guraxetan monotherapy for second line treatment of metastatic castration-resistant prostate cancer in adults and elderly previously treated with only one previous AR-directed therapy and are taxane-based chemonaive. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Curium Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks [177Lu]Lu-PSMA is a form of radionuclide therapy whereby the isotope lutetium-177 (177Lu) is attached to a prostate-specific membrane antigen (PSMA) radioligand to enable targeted delivery of radiation to prostate cancer cells via beta-particle emission. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum in juli 2024. Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Abiraterone met prednison of enzalutamide. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eerder heeft de cieBOM goedkeuring gegeven voor het sluisgeneesmiddel Pluvicto (1). De resultaten van de ECLIPSE studie zijn nog niet bekend (2). Een product met dezelfde stof (177Lu-PNT2002) is ook in ontwikkeling. Er zal een keuze gemaakt moeten worden tussen de varianten van dit type middel. Er staat bovendien een middel bekend, Lu177-PSMA I&T, met dezelfde stof als lutetium (177Lu) zadavotide guraxetan dat momenteel magistraal bereid wordt in verschillende Nederlandse ziekenhuizen (3). Duration of treatment Frequency of administration 1 times every 6 weeks Dosage per administration 200 mCi (7,4 GBq) References NVMO-commissie BOM. 2024 (1); NCT05204927 (ECLIPSE) (2); Expertopinie (3). Additional remarks 200mCi (7,4 GBq) iedere 6 weken voor 6 cycli. Expected patient volume per year Patient volume < 1,645 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom. Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten). Expected cost per patient per year Cost € 87,570.00 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 Additional remarks De kosten zullen mogelijk gelijk zijn aan die van Pluvicto €87.570 per patiënt per jaar. Potential total cost per year Total cost € 144,052,650.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks