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

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.

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.