Extended indication Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to a
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Treosulfan
Domain Hematology
Reason of inclusion Indication extension
Main indication Stem cell transplants
Extended indication Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients, and in paediatric patients older than one month with malignant and non‑malignant diseases.
Proprietary name Trecondi
Manufacturer Medac
Mechanism of action Alkylating agent
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2022
Expected Registration February 2023
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie in januari 2023.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 10 g/m2
References NCT02349906

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References farmacotherapeutisch kompas
Additional remarks - Trecondi, 1.000mg poeder voor oplossing voor infusie: €135,15 - Trecondi, 5.000mg poeder voor oplossing voor infusie: €670,33

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.