Selinexor Medicine 08 June 2021 Extended indication Patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Therapeutic value No estimate possible yet Total cost € 440,000.00 Registration phase Clinical trials Product Active substance Selinexor Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Current proprietary name Already available biosimilars / generics Proprietary name XPOVIO Manufacturer Stemline Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Exportin-1 protein inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Eribuline Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration 2 times a week Dosage per administration 60 mg References NCT02606461 Additional remarks 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 < 11 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks In 2021 werden er 87 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 patiënten aantal mogelijk nog lager uitvallen. Expected cost per patient per year Cost € 40,000.00 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. References https://www.reuters.com/article/us-karyopharm-fda-idUSKCN1TY2FI. Additional remarks In de Verenigde Staten is de lijstprijs per maand bepaald op $22,000 (ongeveer €20.000). De mediane behandelduur is 9 weken wat neerkomt op ongeveer €40.000 per patiënt per jaar. Potential total cost per year Total cost € 440,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Adis insight Additional remarks 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 Additional remarks