Omidubicel

Active substance Omidubicel
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Patients With (Leukemia, Lymphoma, and Myelodysplastic Syndrome (MDS)) who are eligible for allogeneic hematopoietic stem cell transplantation.

Product

Proprietary name NiCord
Manufacturer Gamida Cell Ltd
Mechanism of action Allogeneic modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Fabrikant Gamida Cell.

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional comments Actual primary completion datum in December 2019.

Therapeutic value

Current treatment options Op basis van deze studie: https://pubmed.ncbi.nlm.nih.gov/30523748/ is de behandeling feasible. Klein indicatiegebied met ook de opkomst van haplo stamceltransplantatie als donor source.
Therapeutic value No judgement
Duration of treatment Not found
References NCT02730299. https://pubmed.ncbi.nlm.nih.gov/30523748/.

Expected patient volume per year

Patient volume

< 30

Market share is generally not included unless otherwise stated.

Additional comments Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. Er wordt verwacht dat dit geneesmiddel niet in Nederland ingezet zal worden, het zal maximaal in 5% van de gevallen ingezet worden.

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 Aplastic anaemia; Haemoglobinopathies; Myelodysplastic syndromes; Sickle cell anaemia; Thalassaemia.
References adisinsight
Additional comments Fase 1 - 2 studies.

Other information

There is currently no futher information available.