Version 3

Cabozantinib

Medicine

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 No registration expected

Product

Active substance Cabozantinib
Domain Oncology
Reason of inclusion Indication extension IND
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
Particularity Unknown
ATMP No
Submission date December 2024
Orphan drug No
Registration phase No registration expected
Additional remarks De experimentele arm toonde geen voordeel ten opzichte van de controlearm bij de eindanalyse van OS. https://ir.exelixis.com/static-files/0de8dcd3-8bfb-4c35-8282-54b1317d431e

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
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 doseringen) gevolgd door 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 3 en 584 diagnoses stadium 4 gesteld (1). In totaal zijn dit 995 diagnoses stadium 3 en 4.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information