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Gilteritinib

Extended indication Relapse/Refractory FLT3 gemuteerde AML
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Gilteritinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Leukemia
Extended indication Relapse/Refractory FLT3 gemuteerde AML
Manufacturer Astellas
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks FLT3 inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2019
Expected Registration April 2020
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No judgement
Substantiation Dit geneesmiddel zal waarschijnlijk ook de competitie aangaan met midostaurin en andere flt3 remmers
Frequency of administration 1 times a day
Dosage per administration 120 mg
References NCT02421939; Hovon; Perl et al. Blood 2016 128:1069.
Additional remarks phase 1/2 study: 100 (40%) of 249 patients in the full analysis set achieved a response, with 19 (8%) achieving complete remission, ten (4%) complete remission with incomplete platelet recovery, 46 (18%) complete remission with incomplete haematological recovery, and 25 (10%) partial remission; gaat in toekomstige HOVON studie vergeleken worden met imatinib.

Expected patient volume per year

Patient volume

58 - 70

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR; Levis. Hematology Am Soc Hematol Educ Program. 2013; 2013: 220–226; kanker.nl.
Additional remarks Incidentie van AML patiënten in Nederland is 774 (IKNL 2017) waarvan 30% FLT3 gemuteerd is (232) en waarvan 50%-60% relapse/refractory is (116-139). De fabrikant geeft aan dat het een marktaandeel van 50% verwacht (58-70).

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 FLT3 gemuteerde AML: onderhoudstherapie (na inductie/consolidatie chemotherapie / na allogene stamceltransplantatie) en nieuw gediagnosticeerde patienten die geen standaard chemo kunnen ontvangen.
References Fabrikant; NCT02927262; NCT02997202; NCT02752035.

Other information

There is currently no futher information available.