Mezigdomide Medicine 04 December 2025 Extended indication Mezigdomide in combination with bortezomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have had prior lenalidomide exposure. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Mezigdomide Domain Hematology Reason of inclusion New medicine (specialité) Main indication Multiple Myeloma Extended indication Mezigdomide in combination with bortezomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have had prior lenalidomide exposure. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BMS Portfolio holder BMS Mechanism of action Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2027 Expected Registration 2028 Orphan drug No Registration phase Clinical trials 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 NCT05519085 (SUCCESSOR-1) 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks