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Isatuximab

Sarclisa

Extended indication Isatuximab in combination with pomalidomide and dexamethasone for second line or later treatment of
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Isatuximab
Domain Hematology
Reason of inclusion Indication extension
Main indication Multiple Myeloma
Extended indication Isatuximab in combination with pomalidomide and dexamethasone for second line or later treatment of relapsed and/or refractory multiple myeloma in adults and elderly who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
Proprietary name Sarclisa
Manufacturer Sanofi
Mechanism of action Immunostimulation
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Dit betreft een indicatieuitbreiding van subcutane versus intraveneuze toediening. Sarclisa is goedgekeurd voor de derde lijn in deze setting met IV. Echter wordt Sarclisa in de IRAKLIA trial in de tweede lijn onderzocht.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2025
Expected Registration March 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT05405166 (IRAKLIA)

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.