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Gemcitabine

Extended indication	Intra-arterial Gemcitabine for the treatment of locally advanced pancreatic adenocarcinoma which is unresectable in combination with Nab-paclitaxel following radiotherapy
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Gemcitabine
Domain	Oncology
Reason of inclusion	Indication extension
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	2025
Expected Registration	2026
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.

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 (38mg/ml) bedragen ongeveer $15 voor 5,26ml. 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.

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