Daratumumab Medicine 04 December 2025 Extended indication Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Daratumumab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant. Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Janssen Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP No Submission date June 2026 Expected Registration January 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03901963 (AURIGA) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 16,000.00 - 115,000.00 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 Pakketadvies daratumumab (Darzalex®) bij multipel myeloom (ziekte van Kahler), ZIN 2017. Additional remarks De lijstprijs voor één flacon Darzalex (120mg/ml, 15ml) kost €4.372,66.Inschatting: in lijn met andere indicaties. 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