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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.