Zanzalintinib Medicine 03 December 2024 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 Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Exelixis Portfolio holder Exelixis Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration June 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Aan de hand van een primary completion datum kan een indieningsdatum in juni 2026 en een verwachte registratie in november juni 2027 ingeschat worden. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration References NCT05678673 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Choueiri et al. JAMA Oncol. 2020 (2) Additional remarks In 2022 waren er 930 diagnoses niercelcarcinoom, stadium 3 en 4 (1). Bij 20% van de gevallen is er sprake van een non-clear cell carcinoom (186) (2) Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks