Zanzalintinib Medicine 03 December 2024 Extended indication Zanzalintinib in combination with atezolizumab for third line treatment of microsatellite stable or microsatellite instability low metastatic colorectal cancer in adults and elderly who have progressed after or are intolerant to standard-of-care therapy. 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 Colon cancer Extended indication Zanzalintinib in combination with atezolizumab for third line treatment of microsatellite stable or microsatellite instability low metastatic colorectal cancer in adults and elderly who have progressed after or are intolerant to standard-of-care therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Exelixis Portfolio holder 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 March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Aan de hand van een primary completion datum in augustus 2025 kan een indieningsdatum in november 2025 en een verwachte registratie in december 2026 geschat worden. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog weinig te zeggen over de effectiviteit. Zanzalintinib is een multi kinase remmer, van onder andere VEGFR en c-MET. De controle arm in de stellar 303 studie betreft regorafenib. Regorafenib zorg voor bescheiden overall survival winst, maar voldoet niet aan PASKWIL en wordt in Nederland dan ook in principe niet voorgeschreven. Duration of treatment Frequency of administration Dosage per administration References NCT05425940 (STELLAR-303) 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); Gatalica et al. Fam Cancer. 2016 (2). Additional remarks In 2022 waren er 12.521 diagnoses darmkanker in Nederland (1). Ongeveer 85% van de gevallen laten geen hoog niveau van microsatellite instability zien (2). Omdat dit een derdelijnsbehandeling is zal het uiteindelijke patiëntvolume een fractie van deze groep zijn. Expected cost per patient per year Cost References Additional remarks 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