Temozolomide Medicine 03 June 2025 Extended indication Temozolomide monotherapy for treatment of relapsed or refractory neuroblastoma in infants and toddlers over 1 year of age, children and adolescents. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Temozolomide Domain Oncology Reason of inclusion Indication extension IND Main indication Brain cancer Extended indication Temozolomide monotherapy for treatment of relapsed or refractory neuroblastoma in infants and toddlers over 1 year of age, children and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Temodar Manufacturer Orphelia Portfolio holder Mechanism of action Alkylating agent Route of administration Oral Therapeutical formulation Oral suspension Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2023 Expected Registration May 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Rejected 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 1 times a day Dosage per administration 40mg/ml References 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