Durvalumab Medicine 03 June 2025 Extended indication Neoadjuvant-Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC). (Matterhorn) Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Neoadjuvant-Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC). (Matterhorn) Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NCT04592913 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks EMA verwacht Q2/Q3 2026 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eerste resultaten gepresenteerd op ASCO GI. Er is nog geen PFS/OS data. Echter wel meer responses bij de combinatie (absolute difference of 12%: rates were 7% with FLOT and 19% with durvalumab plus FLOT (odds ratio [OR] = 3.08, P < .00001). Duration of treatment Frequency of administration Dosage per administration References https://meetings.asco.org/2024-asco-gastrointestinal-cancers-symposium/15568?presentation=229135#229135 Additional remarks Wordt onderzocht in NCT04592913 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); expertopinie (2) Additional remarks De incidentie van maagcarcinoom betrof 1.109 (1. Het merendeel wordt geopereerd. Diegene die progressie hebben, vallen af (max 25% valt af) (2). 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