Tucatinib Medicine 10 December 2019 Extended indication Behandeling van HER2 positieve borstkanker in combinatie met Capecitabine en Trastuzumab (2L+) Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Tucatinib Domain Oncology and Hematology Reason of inclusion Generic G Main indication Breast cancer Extended indication Behandeling van HER2 positieve borstkanker in combinatie met Capecitabine en Trastuzumab (2L+) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Array BioPharma Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ERBB 2 receptor antagonists. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2020 Expected Registration March 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks fase 3 studie Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 300 mg References meerdere fase 2 studies (zie clinicaltrials.gov), zie onder andere NCT02614794, fase 3 studie nu ook gestart: NCT03975647 Additional remarks Expected patient volume per year Patient volume < 190 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er zijn zo'n 190 patiënten per jaar met stadium IV HER+ invasief mammacarcinoom, een deel hiervan zal in de 2e lijn of daarop volgende behandeling in aanmerking komen voor dit geneesmiddel. Aantal patiënten in de tweede lijn zal naar verwachting wel toe gaan nemen door betere overleving. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions colorectaal carcinoom References AdisInsight, clinicaltrials.gov Additional remarks Other information Additional remarks