Fezolinetant

Extended indication	Zanzalintinib in combination with nivolumab for first line treatment of unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma in adults and elderly
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Zanzalintinib
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Kidney cancer
Extended indication	Zanzalintinib in combination with nivolumab for first line treatment of unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma in adults and elderly
Portfolio holder	Exelixis
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	October 2025
Expected Registration	November 2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Aan de hand van een primary completion datum in juli 2025 kan een indieningsdatum in oktober 2025 en een verwachte registratie in november 2026 geschat worden.

Therapeutic value	No estimate possible yet
Substantiation	Het effect van sunitinib (controle arm) in non-clear RCC is niet goed onderzocht. Een goed uitgevoerde studie onder deze patiëntpopulatie is lastig doordat het een heterogene populatie betreft.
References	NCT05678673

References	NKR 2022 (1); Choueiri et al. JAMA Oncol. 2020 (2)
Additional remarks	In 2022 waren er 930 diagnoses niercelcarcinoom, stadium III en IV (1). Bij 20% van de gevallen is er sprake van een non-clear cell carcinoom (186) (2)

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.