Isatuximab Medicine 03 December 2024 Extended indication Isatuximab in combination with pomalidomide and dexamethasone for second line or later treatment of relapsed and/or refractory multiple myeloma in adults and elderly who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Isatuximab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Isatuximab in combination with pomalidomide and dexamethasone for second line or later treatment of relapsed and/or refractory multiple myeloma in adults and elderly who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor Current proprietary name Already available biosimilars / generics Proprietary name Sarclisa Manufacturer Sanofi Portfolio holder Mechanism of action Immunostimulation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Dit betreft een indicatieuitbreiding van subcutane versus intraveneuze toediening. Sarclisa is goedgekeurd voor de derde lijn in deze setting met IV. Echter wordt Sarclisa in de IRAKLIA trial in de tweede lijn onderzocht. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date February 2025 Expected Registration March 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie 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 NCT05405166 (IRAKLIA) 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 References Additional remarks Potential total cost per year Total cost 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