Extended indication Bone marrow transplant in MM icm G-CSF.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Motixafortide
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Bone marrow transplant in MM icm G-CSF.
Manufacturer BioLineRx
Mechanism of action Receptor antagonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional remarks Weesgeneesmiddelstatus van de FDA voor stamcel mobilisatie.

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 1.25mg/kg + G-CSF
References NCT03246529.
Additional remarks GENESIS: Tot 2 subcutane injecties van BL-8040 worden verwacht tijdens de studie.

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

References NKR; Pakketadvies daratumumab (Darzalex®) bij multipel myeloom, ZIN 2017.
Additional remarks Jaarlijks aantal nieuwe multipel myeloom patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar en >65 met comorbiditeiten (50%). Dit betekent dat van de maximaal 500 patiënten een deel hiervan in aanmerking zal komen voor deze nieuwe behandeling.

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

Indication extension Yes
Indication extensions PhII: Acute myeloid leukaemia; Pancreatic cancer.

Other information

There is currently no futher information available.