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 ATMP No Submission date December 2026 Expected Registration January 2028 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Op basis van een primary completion datum kan een indieningsdatum in december 2026 en een verwachte registratie in januari 2028 ingeschat 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 4.500mg/m2 References NCT01954992 (1); Ciuleanu et al. EJC. 2009 (2). Additional remarks 4.500mg/m2 gedurende zes uur op dag een van elke cyclus van 21 dagen. 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 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks