Surufatinib Medicine 10 June 2020 Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Surufatinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Hutchison MediPharma Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Surufatinib inhibits tyrosine kinase activity associated with VEGFR and FGFR. Grade 1 (low-grade tumor): These cells divide at a low rate and therefore grow slowly. Grade 2 (intermediate-grade tumor): These cells divide at an intermediate rate. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant heeft aangegeven registratie bij de FDA te plannen, wanneer indiening bij de EMA plaats zal vinden is nog niet bekend. Therapeutic value Current treatment options Huidige behandelopties zijn beperkt, met name chirurgie. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 300 mg References NCT02588170 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 Additional remarks Jaarlijks krijgen in Nederland ruim 700 mensen een neuro-endocrine tumor. 9% van alle neuro-endocrine tumoren ontstaan in de pancreas. Het patiëntaantal voor deze indicatie zal beperkt zijn. Bij komende indicatie-uitbreidingen zullen grotere patiëntvolumes gemoeid 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Overige Neuro Endocriene Tumoren en Biliary cancer. References Clinicaltrials.gov; Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks