Domvanalimab Medicine 06 June 2023 Extended indication previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Domvanalimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Arcus Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: A humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the co-inhibitory molecule and immune checkpoint inhibitor T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains (TIGIT), with potential immune checkpoint inhibitory activity. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 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 Op dit moment loopt de studie nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References NCT05568095 Additional remarks Expected patient volume per year Patient volume < 510 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020 (1); Additional remarks De incidentie van maagcarcinoom betrof 1.063 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt ervan uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Dit is echter significant lager dan het gedeelte met maagcarcinoom. 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 Zie indicatie-uitbreiding voor NSCLC die opgenomen is op de Horizonscan References AdisInsight Additional remarks Other information Additional remarks