BL-8040

Active substance BL-8040
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Stem cell transplants
Extended indication Bone marrow transplant in MM icm G-CSF.

Product

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 2020
Expected Registration 2021
Registration phase Clinical trials
Additional comments Weesgeneesmiddelstatus van de FDA voor stamcel mobilisatie.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Dosage per administration 1.25mg/kg + G-CSF
References NCT03246529
Additional comments 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 comments Jaarlijks aantal nieuwe multipel myeloma 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.