Talquetamab Medicine 04 December 2025 Extended indication Talquetamab in combination with daratumumab and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Talquetamab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Talquetamab in combination with daratumumab and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide. Current proprietary name Already available biosimilars / generics Proprietary name Talvey Manufacturer Janssen Portfolio holder Janssen Mechanism of action Route of administration Subcutaneous Therapeutical formulation Concentrate for solution for injection / infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date 2027 Expected Registration June 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De TAL DARA DEX - TRIMM2 studie is net gepubliceerd. Hierin werd, non-head to head vergeleken met TAL mono. Er werd ongeveer een verdubbeling van de PFS gevonden. Ook al is het dus niet direct vergeleken. In Nederland zou deze behandeling in tweede lijn met Dara-Kd vergeleken kunnen worden bij jongere patiënten, echter is er geen uitspraak te doen over de meerwaarde. Duration of treatment Frequency of administration Dosage per administration References NCT05455320 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie (1). Additional remarks Op basis van de PERSEUS studie zal wellicht onderhoudstherapie met dara toegepast gaan worden, indien refractair voor Dara zal Tal-Dara-dex daarom niet toegepast worden. Er worden weinig tot geen patiënten verwacht. Ouderen krijgen alleen Dara-Rd continue en dus geen toepassing van dit regime. Expected cost per patient per year Cost € 170,000.00 - 175,000.00 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 Sluisplaatsing talquetamab (Talvey) (Staatscourant 2023-25660) Additional remarks Op basis van de eerdere sluisplaatsing van vierdelijns behandeling met talquetamab bedragen de behandelkosten ongeveer € 172.000 per patiënt per behandeling. 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