Sv-br-1-gm Medicine 04 December 2025 Extended indication Sv-br-1-gm in combination with cyclophosphamide, interferon, retifanlimab for third line or later treatment of advanced metastatic or locally recurrent Breast cancer in adults and elderly with no approved alternative therapies available. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Sv-br-1-gm Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Sv-br-1-gm in combination with cyclophosphamide, interferon, retifanlimab for third line or later treatment of advanced metastatic or locally recurrent Breast cancer in adults and elderly with no approved alternative therapies available. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BriaCell Portfolio holder BriaCell Mechanism of action Immunostimulation Route of administration Intrader meal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Bria-IMT™ (SV-BR-1-GM) is een kant-en-klare, doelgerichte cellulaire immunotherapie, een genetisch gemanipuleerde humane borstkankercellijn met kenmerken van immuun cellen. Het werkingsmechanisme is gebaseerd op de hypothese dat Bria-IMT™ zowel indirect als direct de kanker bestrijdende cellen in het lichaam stimuleert om borstkankertumoren aan te vallen en te vernietigen. Indirect produceert Bria-IMT™ borstkanker-"antigenen" (eiwitten die tot expressie komen in borstkankercellen) die vervolgens worden herkend door het immuunsysteem, dat vervolgens diezelfde antigenen in de borstkanker van een patiënt kan herkennen en de kanker kan aanvallen. Bovendien lijkt Bria-IMT™ deze kanker bestrijdende immuun cellen direct aanzienlijk te stimuleren, waardoor de reactie van het lichaam wordt versterkt. Het Bria-IMT™-regime bestaat uit SV-BR-1-GM, cyclofosfamide en interferon. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Yes Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Potentiële ATMP. 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 NCT06072612 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Additional remarks In 2022 kregen 2.504 mensen de diagnose invasief mammacarcinoom (stadium 3 en 4) (1). Expected cost per patient per year Cost References IHSI Additional remarks €460.000 per patiënt per jaar. 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