Selinexor Medicine 12 June 2019 Extended indication Patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Selinexor Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Multiple Myeloma Extended indication Patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Karyopharm Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CRM1 nuclear export inhibitor Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date February 2019 Expected Registration October 2019 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 2 times a week Dosage per administration 80 mg References NCT02336815 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies daratumumab Additional remarks Het geschatte aantal patiënten wat in de derde lijn behandeld wordt voor multiple myeloom is 418. Hoeveel hiervan zal naar de 4e lijn toe gaan? 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 Liposarcoma; Endometrial cancer; Acute myeloid leukaemia; Breast cancer; Cervical cancer; Cutaneous T-cell lymphoma; Diffuse large B cell lymphoma; Glioblastoma; Myelodysplastic syndromes; Neuroendocrine tumours; Ovarian cancer; Peripheral T-cell lymphoma; Prostate cancer; Small cell lung cancer; Squamous cell cancer; Thymoma; Chronic myelomonocytic leukaemia; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Soft tissue sarcoma References Clinicaltrials.gov Additional remarks Other information Additional remarks