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Mosunetuzumab

Lunsumio

Extended indication Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refrac
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Mosunetuzumab
Domain Hematology
Reason of inclusion Indication extension
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy
Proprietary name Lunsumio
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2025
Expected Registration June 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van primary completion datum in augustus 2025.

Therapeutic value

Therapeutic value No estimate possible yet
References EPAR Lunsumio; NCT04712097 (CELESTIMO)
Additional remarks Doseringsschema met 1+2+60 mg in cyclus 1, 60 mg in cyclus 2 en 30 mg in de daaropvolgende cycli.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 83,325.00
References Medicijnkosten.nl
Additional remarks Volgens het doseringsschema kosten 8 cycli Lunsumio €83.325 (excl. BTW) (1).

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.