Brentuximab vedotin Medicine 04 June 2024 Extended indication Extension of indication for ADCETRIS to include treatment for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Brentuximab vedotin Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Extension of indication for ADCETRIS to include treatment for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone. Current proprietary name Already available biosimilars / generics Proprietary name Adcetris Manufacturer Takeda Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antibody-drug conjugate (ADC) bestaande uit een anti-CD30-gericht monoklonaal antilichaam verbonden aan het antineoplastische middel monomethyl auristatin E (MMAE). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2024 Expected Registration January 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks NCT02932410 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 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