Extended indication Acute lymphoblastic leukaemia (ALL), Philadelphia-negative
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Crisantaspase
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication ALL
Extended indication Acute lymphoblastic leukaemia (ALL), Philadelphia-negative
Manufacturer Jazz
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments L-Asparaginase encapsulated inside donor-derived red blood cells.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2022
Expected Registration August 2023
Orphan drug Yes
Registration phase Registration application pending
Additional comments Eerder ingediend in februari 2018 en vervolgens teruggetrokken. Er vond een herindiening plaats in juni 2022.

Therapeutic value

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

Expected patient volume per year

Patient volume

13 - 40

Market share is generally not included unless otherwise stated.

References NKR2016; Blinatumomab
Additional comments 40 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Ca 30% krijgt een eerste recidief. Dit komt overeen met ca 13 patiënten per jaar.

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

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.