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Brentuximab vedotin

Adcetris

Extended indication Extension of indication for ADCETRIS to include treatment for adult patients with previously untreat
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Brentuximab vedotin
Domain Hematology
Reason of inclusion Indication extension
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.
Proprietary name Adcetris
Manufacturer Takeda
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
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
Submission date April 2024
Expected Registration January 2025
Orphan drug Yes
Registration phase Registration application pending
Additional remarks NCT02932410

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.