Cabozantinib

Extended indication	Cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced or metastatic renal cell carcinoma.
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Cabozantinib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Kidney cancer
Extended indication	Cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced or metastatic renal cell carcinoma.
Proprietary name	Cabometyx
Manufacturer	Ipsen
Mechanism of action	Tyrosine kinase inhibitor
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	2024
Expected Registration	2025
Registration phase	Clinical trials
Additional remarks	NCT03937219

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	De kans op progressie-vrije overleving bij 12 maanden was 0,57 in de experimentele groep en 0,49 in de controle groep (hazard ratio, 0,73; 95% confidence interval, 0.57 to 0.94; P = 0.01). Er zijn nog geen data bekend over algehele overleving. Er moet goed over worden nagedacht of het juist is om triple therapie in de eerste lijn te geven.
References	NCT03937219 (COSMIC-313); Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma August 3, 2023 N Engl J Med 2023; 389:476-478;
Additional remarks	Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab

Expected patient volume per year

Patient volume	< 995 Market share is generally not included unless otherwise stated.
References	NKR 2021
Additional remarks	In 2021 werden er 411 diagnoses niercelcarcinoom stadium III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV.

Patient volume

< 995

Market share is generally not included unless otherwise stated.

References

NKR 2021

Additional remarks

In 2021 werden er 411 diagnoses niercelcarcinoom stadium III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.