Version 2

Iopofosine I 131

Medicine

Extended indication Treatment of patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Iopofosine I 131
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication CLL
Extended indication Treatment of patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy.
Manufacturer Cellectar
Mechanism of action Unknown
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: Cellectar Biosciences

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks NCT02952508

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.
Substantiation Er wordt geen plek verwacht voor dit middel bij CLL, gezien de verwachte hoge toxiciteit en de noodzakelijke voorzorgsmaatregelen vanwege straling, tegenover een behandellandschap met covalente en non-covalente BTK-remmers, BCL-2 remmers, anti-CD20 antistoffen, bi-specifieke antistoffen en mogelijke combinaties van deze middelen voor CLL.
References Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information