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Zanubrutinib

Brukinsa

Extended indication Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refr
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Zanubrutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Proprietary name Brukinsa
Manufacturer Astex
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2023
Expected Registration December 2024
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie oktober 2023

Therapeutic value

Current treatment options CD-20
Therapeutic value No estimate possible yet
Substantiation De rosewood trial (ZInzani JCO 2023) laat een ORR voordeel zien van Zanubrutinib-obinutuzumab versus obinutuzumab monotherapie (69% versus 46%), echter heeft CD20 monotherapie al niet de voorkeur in de behandelrichtlijn. Er zijn veel andere behandelopties die eerder ingezet zullen worden dan de CD20 BTK-remmer combinatietherapie.
References NCT03332017

Expected patient volume per year

Patient volume

90 - 135

Market share is generally not included unless otherwise stated.
References Pakketadvies sluisgeneesmiddel axicabtagene ciloleucel (Yescarta®) voor volwassenen met recidiverend of refractair DLBCL en PMBCL na 2 of meer lijnen systemische therapie, ZIN 2019
Additional remarks In de budget impact analyse van het pakketadvies wordt een inschatting gemaakt van 90-135 patiënten 3 jaar na marktintroductie. De verwachting is dat door concurrentie zanubrutinib nauwelijks ingezet zal worden voor deze indicatie.

Expected cost per patient per year

References In de Verenigde Staten is de lijstprijs voor zanubrutinib gesteld op $12.935 (ongeveer €11.500).

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.