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Eryaspase (Asparaginase)

Graspa

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

Product

Active substance Eryaspase (Asparaginase)
Domain Oncology and Hematology
Main indication Leukemia
Extended indication Acute lymphoblastic leukaemia (ALL), Philadelphia-negative
Proprietary name Graspa
Manufacturer ERYtech
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
Particularity New medicine
Submission date February 2018
Expected Registration March 2019
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
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

13 - 40

Market share is generally not included unless otherwise stated.
References NKR; Blinatumomab
Additional remarks NKR 2016: 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.