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Obinutuzumab

Gazyvaro

Extended indication Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrom
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Obinutuzumab
Domain Hematology
Reason of inclusion Indication extension
Main indication Other hematology
Extended indication Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.
Proprietary name Gazyvaro
Manufacturer Roche
Portfolio holder Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date December 2022
Expected Registration October 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Obinituzumab zal preventief of bij symptomen gegeven kunnen worden zeven dagen voor de eerste gift glofitamab.

Expected patient volume per year

Patient volume

126 - 168

Market share is generally not included unless otherwise stated.
Additional remarks Indien obinutuzumab bij alle glofitamab behandeling ingezet zal worden zou het patiëntvolume mogelijk tussen de 126 tot 168 patiënten liggen gebaseerd op de inschatting van glofitamab.

Expected cost per patient per year

References medicijnkosten
Additional remarks Prijs voor huidige indicatie is €3.957,86 per 1000 mg

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.