Crisantaspase

Extended indication	Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase
Therapeutic value	No estimate possible yet
Registration phase	Registered

Product

Active substance	Crisantaspase
Domain	Hematology
Reason of inclusion	New medicine (specialité)
Main indication	ALL
Extended indication	Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase
Proprietary name	Enrylaze
Manufacturer	Jazz
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	L-Asparaginase encapsulated inside donor-derived red blood cells.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	April 2023
Expected Registration	September 2023
Orphan drug	Yes
Registration phase	Registered
Additional remarks	Positieve CHMP-opinie juli 2023

Therapeutic value

Therapeutic value	No estimate possible yet
Dosage per administration	150 IU/kg
References	NCT01518517
Additional remarks	Minimaal 2 en maximaal 10 toedieningen om de 3 dagen in combinatie met standaard chemotherapie (COOPRALL).

Expected patient volume per year

Patient volume	26 - 81 Market share is generally not included unless otherwise stated.
References	NKR2020; Blinatumomab
Additional remarks	Er zijn jaarlijks 81 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Circa 30% van de patiënten krijgt een eerste recidief. Dit komt overeen met ongeveer 26 patiënten per jaar.

Patient volume

26 - 81

Market share is generally not included unless otherwise stated.

References

NKR2020; Blinatumomab

Additional remarks

Er zijn jaarlijks 81 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Circa 30% van de patiënten krijgt een eerste recidief. Dit komt overeen met ongeveer 26 patiënten per jaar.

Expected cost per patient per year

Additional remarks	De prijs zal mogelijk vergelijkbaar zijn met andere vormen van crisantaspase die al op de markt zijn.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use	No

Indication extension

Indication extension	No

Other information

There is currently no futher information available.