Tivozanib

Active substance
Tivozanib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Kidney cancer
Extended indication
Refractory advanced renal cell cancer third-line or fourth-line therapy.

1. Product

Proprietary name
Fotivda
Manufacturer
Kyowa
Mechanism of action
Angiogenesis inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Fotivda is een VEGF-receptor antagonist en wordt op dit moment al als eerstelijns behandeling ingezet bij niercelcarcinoom.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Verwachte indiening- en registratiedatum op basis van de actual primary completion datum in december 2018 van de fase 3 studie.

3. Therapeutic value

Current treatment options
Andere VEGF receptor antagonisten, bijvoorbeeld sorafenib.
Therapeutic value
No judgement
Substantiation
Er wordt voor deze indicatie veel concurrentie verwacht.
Duration of treatment
Not found
Frequency of administration
1 times every 4 weeks
Dosage per administration
1 - 5 mg
References
NCT02627963

4. Expected patient volume per year

References
NKR
Additional comments
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.

5. Expected cost per patient per year

References
medicijnkosten.nl
Additional comments
€ 154,01 per capsule van 1.340 mg.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Soft tissue sarcoma
References
clinicaltrials.org
Additional comments
Lopende fase 2 studie.

9. Other information

There is currently no futher information available.