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Zanubrutinib

Brukinsa

Extended indication Extension of indication to include in combination with obinutuzumab treatment of adult patients with
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Zanubrutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Extension of indication to include in combination with obinutuzumab treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic treatments.
Proprietary name Brukinsa
Manufacturer Astex
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 January 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.