Napabucasin Medicine 12 June 2019 Extended indication Metastatic gastric or gastroesophageal adenocarcinoma in adults, 2L+, in combination with paclitaxel. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Napabucasin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Metastatic gastric or gastroesophageal adenocarcinoma in adults, 2L+, in combination with paclitaxel. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Boston Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks First-in-class cancer stemness inhibitor that targets STAT3. Resultaten fase III studie naar verwachting in 2021. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 7 week / weeks Frequency of administration 2 times a day Dosage per administration 480 mg References Jonker et al. Lancet Gastroenterol Hepatol. 2018 Apr;3(4):263-270. Additional remarks Expected patient volume per year Patient volume < 137 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer twee derde van deze patiënten werd behandeld in de 1e lijn (370 patiënten). Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37% (137 patiënten). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks