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Eryaspase (Asparaginase)

Graspa

Extended indication Behandeling van pancreatic adenocarcinoma die gefaald hebben op eerstelijns therapie.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Eryaspase (Asparaginase)
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Pancreatic cancer
Extended indication Behandeling van pancreatic adenocarcinoma die gefaald hebben op eerstelijns therapie.
Proprietary name Graspa
Manufacturer ERYtech
Mechanism of action Enzyme
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Asparagine modulator

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional remarks Estimated Primary Completion Date November 2020 phase 3.

Therapeutic value

Current treatment options chemotherapie
Therapeutic value No estimate possible yet
Frequency of administration 1 times every 2 weeks
Dosage per administration 100 U/kg
References NCT03665441
Additional remarks Eryaspase (Asparaginase) wordt naast chemotherapie gegeven.

Expected patient volume per year

References NKR
Additional remarks In totaal zijn er 1.743 patiënten met stadium III en stadium IV alvleesklierkanker. Gezien de nieuwe behandelopties voor pancreascarcinoom is het nog onduidelijk hoeveel patiënten er in de tweedelijn zullen worden behandeld.

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

There is currently nothing known about off label use.

Indication extension

Indication extension No
References AdisInsight
Additional remarks Wel voor andere indicaties onderzocht (onder andere borstkanker), maar geen indicatie-uitbreidingen in de komende 2 jaar verwacht.

Other information

There is currently no futher information available.