Extended indication Patients diagnosed with advanced unresectable dedifferentiated liposarcoma.
Therapeutic value No estimate possible yet
Total cost 480,000.00
Registration phase Clinical trials

Product

Active substance Selinexor
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Patients diagnosed with advanced unresectable dedifferentiated liposarcoma.
Proprietary name XPOVIO
Manufacturer Karyopharm
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Exportin-1 protein inhibitor.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Registration phase Clinical trials
Additional comments Indieningsdatum gebaseerd op primary completion datum in november 2020.

Therapeutic value

Current treatment options Eribuline
Therapeutic value No estimate possible yet
Substantiation De resultaten van de SEAL studie toonden een mediane PFS in de XPOVIO arm aan van 2,83 maanden vergeleken met 2,07 maanden in de placebo arm (hazard ratio (HR)=0.70; p=0.023). Het is nog niet duidelijk of dit voldoende zal zijn voor een positief advies.
Frequency of administration 2 times a week
Dosage per administration 60 mg
References NCT02606461
Additional comments Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.

Expected patient volume per year

Patient volume

< 12

Market share is generally not included unless otherwise stated.

References https://www.iknl.nl/kankersoorten/bot-en-wekedelenkanker/registratie/incidentie
Additional comments In 2017 en 2018 werden er gemiddeld iets minder dan 100 liposarcomen gediagnosticeerd. Van deze diagnosis betrof 12% een uitgezaaide vorm. In de inclusiecriteria van de studie staat dat patiënten minimaal 2 eerdere lijnen van systemische therapie gehad moeten hebben dus zal dit patiëntenaantal mogelijk nog lager uitvallen.

Expected cost per patient per year

Cost 40,000.00
References https://www.reuters.com/article/us-karyopharm-fda-idUSKCN1TY2FI.
Additional comments In de Verenigde Staten is de lijstprijs per maand bepaald op $22.000 (~€20.000). De mediane behandelduur is 9 weken wat neerkomt op ongeveer €40.000.

Potential total cost per year

Total cost

480,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

References Adis insight
Additional comments Momenteel wordt selinexorvoor de volgende indicaties in fase 3 of fase 2-3 studies onderzocht: Endometrial cancer; Acute myeloid leukaemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma

Other information

There is currently no futher information available.