Masitinib Medicine 09 January 2018 Extended indication Gastro Intestinale Stroma Tumor (GIST) Therapeutic value No judgement Total cost 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) Current proprietary name Already available biosimilars / generics Proprietary name Masican Manufacturer AB Science Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice 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 Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 0 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 waren er 50 diagnoses van GIST stadium VI. De kans op een plek in de richtlijn lijkt klein. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere PhIII studies. References Additional remarks Other information Additional remarks