Tivozanib Medicine 10 June 2020 Extended indication Refractory advanced renal cell cancer third-line or fourth-line therapy. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Tivozanib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Refractory advanced renal cell cancer third-line or fourth-line therapy. Current proprietary name Already available biosimilars / generics Proprietary name Fotivda Manufacturer Kyowa Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fotivda is een VEGF-receptor antagonist en wordt op dit moment al als eerstelijns behandeling ingezet bij niercelcarcinoom. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Verwachte indiening- en registratiedatum op basis van de actual primary completion datum in december 2018 van de fase 3 studie. Therapeutic value Current treatment options Andere VEGF receptor antagonisten, bijvoorbeeld sorafenib. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt voor deze indicatie veel concurrentie verwacht. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1 - 5 mg References NCT02627963 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 hadden in totaal 2.672 patiënten nierkanker in Nederland. 953 patiënten hadden een stadium 3 of 4 carcinoom. De werkgroep verwacht dat het aantal patiënten dat hiervoor in aanmerking komt in de derde of vierde lijn beperkt zal zijn. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks € 154,01 per capsule van 1.340 mg. 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 Soft tissue sarcoma References clinicaltrials.org Additional remarks Lopende fase 2 studie. Other information Additional remarks