Db-1303/bnt323 Medicine 03 June 2025 Extended indication Db-1303/bnt323 monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Db-1303/bnt323 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Db-1303/bnt323 monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biontech Portfolio holder Mechanism of action Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 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 Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 8mg/kg References NCT06018337 Additional remarks 8mg/kg intraveneuze dosis op dag 1 van elke cyclus, elke 3 weken. Expected patient volume per year Patient volume < 1,353 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); bcrf.org 2025 (2) Additional remarks In 2022 kregen 2.504 mensen de diagnose invasief mammacarcinoom (stadium 3 en 4) (1). Hiervan is 54% HER2-low (IHC 2+/ISH- or IHC 1+ (ISH- or untested)) (n=1353). Het aantal patiënten dat in aanmerking komt voor dit middel zal lager zijn, omdat het een behandeling in de derde lijn betreft. 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