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.

1. Product

Manufacturer
BioLineRx
Mechanism of action
Receptor antagonist
Route of administration
Subcutaneous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Registration phase
Clinical trials
Additional comments
Weesgeneesmiddelstatus van de FDA voor stamcel mobilisatie.

3. 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

4. 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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.