Eryaspase (Asparaginase)

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Registration phase	Withdrawn

Product

Active substance	Eryaspase (Asparaginase)
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
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 route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	February 2018
Orphan drug	Yes
Registration phase	Withdrawn
Additional remarks	https://scrip.pharmaintelligence.informa.com/SC123309/Erytech-Pulls-Graspa-ALL-Filing-To-Focus-On-Pancreatic-Cancer. CHMP-opinie in juli 2018.

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).

Patient volume	13 - 40 Market share is generally not included unless otherwise stated.
References	NKR2016; Blinatumomab
Additional remarks	40 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Ca 30% krijgt een eerste recidief. Dit komt overeen met ca 13 patiënten per jaar.

Patient volume

13 - 40

Market share is generally not included unless otherwise stated.

References

NKR2016; Blinatumomab

Additional remarks

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

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

Off label use	No

Indication extension	No

There is currently no futher information available.