Glufosfamide Medicine 03 December 2024 Extended indication Glufosfamide monotherapy for second line treatment of metastatic pancreatic adenocarcinoma in adults and elderly who have disease progression during or after treatment with gemcitabine Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Glufosfamide Domain Oncology Reason of inclusion New medicine (specialité) Main indication Pancreatic cancer Extended indication Glufosfamide monotherapy for second line treatment of metastatic pancreatic adenocarcinoma in adults and elderly who have disease progression during or after treatment with gemcitabine Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eleison Portfolio holder Mechanism of action Cytostatic Route of administration Intravenous Therapeutical formulation Powder for injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2025 Expected Registration October 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Op basis van een primary completion datum in juni 2025 kan een indieningsdatum in september 2025 en een verwachte registratie in oktober 2026 geschat worden. Therapeutic value Current treatment options Eerste lijn: FOLFIRINOX of NAB-paclitaxel met gemcitabine. Tweede lijn: geen standaard behandeloptie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend van de fase 3 studie (1). Een eerdere studie liet geen benefit zien (2). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 4500 mg/m2 References NCT01954992 (1); Ciuleanu et al. EJC. 2009 (2). Additional remarks 4.500mg/m2 over 6 hours on day 1 of each 21-day cycle. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1) Additional remarks In 2022 waren er 2.051 diagnoses alvleesklierkanker, stadium III en IV (1). Gezien de nieuwe behandelopties voor pancreascarcinoom is het nog onduidelijk hoeveel patiënten er in de tweedelijn zullen worden behandeld. 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