Obinutuzumab

Extended indication	Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.
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	February 2024
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. De verwachting CRS 63% na glofitamab ondanks obinutuzumab, de verwachting is dat er dan alsnog CRS therapie gegeven moet worden.

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.

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.