Expand all sections

Tivozanib

Fotivda

Extended indication Refractory advanced renal cell cancer third-line or fourth-line therapy.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tivozanib
Domain Oncology
Reason of inclusion Indication extension
Main indication Kidney cancer
Extended indication Refractory advanced renal cell cancer third-line or fourth-line therapy.
Proprietary name Fotivda
Manufacturer Kyowa
Mechanism of action Angiogenesis inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
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)
Submission date 2023
Expected Registration 2024
Orphan drug Yes
Registration phase Clinical trials
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 estimate possible yet
Substantiation Er wordt voor deze indicatie veel concurrentie verwacht.
Frequency of administration 1 times every 4 weeks
Dosage per administration 1 - 5 mg
References NCT02627963

Expected patient volume per year

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 2,000.00 - 10,000.00
References Medicijnkosten.nl.
Additional remarks €154,01 per capsule van 890 mcg en 1.340mcg (verkrijgbaar in twee verschillende sterktes).

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 Soft tissue sarcoma
References Clinicaltrials.org
Additional remarks Lopende fase 2 studie.

Other information

There is currently no futher information available.