Tucatinib Medicine 04 December 2025 Extended indication Treatment of patients with unresectable locally advanced or metastatic HER2 positive colorectal cancer. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tucatinib Domain Oncology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication Treatment of patients with unresectable locally advanced or metastatic HER2 positive colorectal cancer. Current proprietary name Already available biosimilars / generics Proprietary name Tukysa Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Tucatinib bindt zich aan tyrosinekinase (een enzym) van HER2, waardoor de signalering van PI3-kinase en MAP-kinase wordt verminderd. Verminderde signalering helpt celgroei te blokkeren en leidt tot celdood. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2027 Expected Registration December 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de MOUNTAINEER-03 fase 3 studie wordt tucatinib + trastuzumab + mFOLFOX6 vergeleken met (1) mFOLFOX6, (2) mFOLFOX6 + bevacizumab, of (3) mFOLFOX6 + cetuximab. Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 2 times a day Dosage per administration 300mg References NCT05253651 (MOUNTAINEER-03) Additional remarks Expected patient volume per year Patient volume 267 - 445 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Patel et al. J Pers Med. 2019 (2). Additional remarks In Nederland waren in 2022 8.907 gevallen van darmkanker, stadium II t/m IV (1). Van de colorectaal carcinoom patiënten is naar verwachting 3 tot 5% HER2-positief (2). Expected cost per patient per year Cost References Taxe november 2025 Additional remarks De behandelduur is nog niet bekend. De apotheekinkoopprijs voor Tukysa is €3.976,37 exclusief BTW per verpakking van 84 stuks in de dosering van 150mg. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks