Extended indication Gastro Intestinale Stroma Tumor (GIST)
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Masitinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication Gastro Intestinale Stroma Tumor (GIST)
Proprietary name Masican
Manufacturer AB Science
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase Clinical trials
Additional remarks Wordt onderzocht in veel verschillende indicaties. Eerst in mastocytosis, AML, etc. Negatieve CHMP-opinie voor mastocytosis en AML in september 2017.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

0 - 50

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks In 2016 waren er 50 diagnoses van GIST stadium IV. De kans op een plek in de richtlijn lijkt klein.

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 Yes
Indication extensions Er lopen meerdere PhIII studies.

Other information

There is currently no futher information available.