Ivospemin Medicine 04 December 2025 Extended indication Ivospemin in combination with nab-paclitaxel and gemcitabine for first line or later treatment of metastatic BRCA-negative ductal adenocarcinoma of pancreas in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ivospemin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Extended indication Ivospemin in combination with nab-paclitaxel and gemcitabine for first line or later treatment of metastatic BRCA-negative ductal adenocarcinoma of pancreas in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Panbela Portfolio holder Panbela Mechanism of action Route of administration Intravenous Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2026 Expected Registration December 2027 Orphan drug Yes 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 Duration of treatment Frequency of administration 1 times a day Dosage per administration ivospemin: 2,0 tot 2,5mg/kg per infusie References NCT03412799 (ASPIRE) Additional remarks Ivospemin: dagen 1, 3, 5, 15, 17, 19 van elke 28-daagse cyclus; nab-paclitaxel/gemcitabine: standaard frequentie (bijvoorbeeld wekelijks x3/q28d); Expected patient volume per year Patient volume < 1,200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) IKNL. Nederlandse Kankerregistratie – Pancreascarcinoom. https://iknl.nl/nkr-cijfers (2) Golan T et al. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019;381(4):317–327. DOI: 10.1056/NEJMoa1903387. Additional remarks Jaarlijks worden in Nederland ongeveer 3.000 nieuwe gevallen van pancreascarcinoom vastgesteld, waarvan circa 90% ductaal adenocarcinoom betreft (1). Ongeveer 50% van deze patiënten heeft bij diagnose gemetastaseerde ziekte, en het merendeel daarvan (85 tot 90%) is BRCA-negatief (2). Daarmee wordt het aantal patiënten dat jaarlijks in aanmerking kan komen voor behandeling met Ivospemin in combinatie met nab-paclitaxel en gemcitabine geschat op 1.000 tot 1.200 patiënten in Nederland. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks