Extended indication Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome
Therapeutic value No estimate possible yet
Registration phase No registration expected

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
Registration phase No registration expected
Additional remarks Deze registratie is teruggetrokken. https://www.ema.europa.eu/en/medicines/human/variation/gazyvaro

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 1.000mg

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.