Expand all sections

Gemcitabine

Extended indication Intra-arterial Gemcitabine for the treatment of locally advanced pancreatic adenocarcinoma which is
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Gemcitabine
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Pancreatic cancer
Extended indication Intra-arterial Gemcitabine for the treatment of locally advanced pancreatic adenocarcinoma which is unresectable in combination with Nab-paclitaxel following radiotherapy
Manufacturer RenovoRX
Route of administration Intra-arterial
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De studieopzet is heel anders dan de praktijk en behandelrichtlijn in Nederland op dit moment. Data worden nog afgewacht.
Duration of treatment Average 4 month / months
Frequency of administration 1 times every 2 weeks
Dosage per administration 1,000 mg/m2
References NCT03257033
Additional remarks IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.

Expected patient volume per year

Patient volume

503

Market share is generally not included unless otherwise stated.
References (1) IKNL 2021; (2) https://iknl.nl/kankersoorten/hpb-tumoren/registratie/incidentie
Additional remarks In 2021 waren er in totaal 2.922 patiënten met een pancreascarcinoom, waarvan ongeveer 530 patiënten met stadium 3 (1). De meest voorkomende vorm is het van het type adenocarcinoom (95%) (2). Voor deze behandeling zullen circa 503 patiënten in aanmerking komen.

Expected cost per patient per year

References Drugs.com
Additional remarks De kosten in de Verenigde Staten voor de intraveneuze oplossing van gemcitabine (38 mg/ml) bedragen ongeveer $ 15 voor 5,26 milliliter. De prijs in de Verenigde Staten liggen doorgaans hoger dan in Nederland.

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.