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Glufosfamide

Extended indication Glufosfamide monotherapy for second line treatment of metastatic pancreatic adenocarcinoma in adults
Therapeutic value No estimate possible yet
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
Manufacturer Eleison
Mechanism of action Cytostatic
Route of administration Intravenous
Therapeutical formulation Powder for injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2025
Expected Registration October 2026
Orphan drug Yes
Registration phase Clinical trials
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
Substantiation Er zijn nog geen resultaten bekend van de fase 3 studie (1). Een eerdere studie liet geen benefit zien (2).
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

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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.