Lisocabtagene maraleucel Medicine 03 June 2025 Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lisocabtagene maraleucel Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant. Current proprietary name Already available biosimilars / generics Proprietary name Breyanzi Manufacturer BMS Portfolio holder Mechanism of action Autologous modified cell therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CD19-directed genetically modified autologous cellular immunotherapy. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date April 2025 Expected Registration February 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice 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 Duration of treatment Frequency of administration Dosage per administration References NCT04245839 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