Tinengotinib Medicine 04 December 2025 Extended indication Tinengotinib monotherapy for second line or later treatment of refractory/relapsed, metastatic, unresectable, FGFR-altered cholangiocarcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tinengotinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Liver cancer Extended indication Tinengotinib monotherapy for second line or later treatment of refractory/relapsed, metastatic, unresectable, FGFR-altered cholangiocarcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer TransThera Portfolio holder TransThera Mechanism of action Tyrosine kinase inhibitor 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 August 2026 Expected Registration September 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Pemigatinib, futibatinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er loopt momenteel een studie naar tinengotinib bij patiënten met FGFR-gemuteerd galwegcarcinoom: in deel A wordt de juiste dosering onderzocht (8mg versus 10mg) en in deel B wordt de behandeling vergeleken met standaard chemotherapie (FOLFOX of FOLFIRI), met progressievrije overleving als eindpunt. Er zijn nog geen resultaten beschikbaar. Tinengotinib lijkt op andere FGFR-remmers zoals pemigatinib (waarvoor een negatief BOM-advies geldt) en futibatinib, waarvan de resultaten tot nu toe gunstiger lijken (zie NCT04093362, NEJM 2023). Duration of treatment Frequency of administration 1 times a day Dosage per administration 8 of 10mg References NCT05948475 (FIRST-308); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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