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Avapritinib

Extended indication Treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Avapritinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication Treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)
Manufacturer Blueprint Medicines
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration August 2020
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Estimated Primary Completion Date 04-2021 phase III trial.

Therapeutic value

Current treatment options imatinib, sunitinib en regorafenib
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 300 mg
References NCT03465722

Expected patient volume per year

Patient volume

25 - 50

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks In 2016 waren er 50 diagnoses van GIST stadium IV. Inschatting: 25-50 patiënten per jaar, ervan uitgaande dat niet iedereen in de derdelijn behandeld wordt.

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 Ook onderzocht bij: Solide tumoren en Systemic mastocytosis. Echter, nog geen fase III studies dus komende 2 jaar deze indicatie-uitbreidingen nog niet verwacht.

Other information

There is currently no futher information available.