Extended indication

In combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment of adu

Therapeutic value

Possible added value

Registration phase

Clinical trials

Product

Active substance

Zolbetuximab

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Stomach cancer

Extended indication

In combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment of adult patients with locally advanced unresectable and/or metastatic adenocarcinoma of the stomach and gastro-esophageal junction that is HER2- and CLDN18.2+ (≥75% of tumor cells) as determined by a validated assay.

Proprietary name

Nog niet bekend

Manufacturer

Astellas

Mechanism of action

Immunostimulation

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

October 2022

Expected Registration

October 2023

Orphan drug

Yes

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening in oktober 2022 en registratie in oktober 2023.

Therapeutic value

Current treatment options

Huidige behandelopties zijn CAPOX / mFOLFOX.

Therapeutic value

Possible added value

Substantiation

First in class, nieuwe target therapie.

Frequency of administration

1 times every 3 weeks

Dosage per administration

600-800 mg/m2

References
NCT03653507

Expected patient volume per year

Patient volume

75 - 100

Market share is generally not included unless otherwise stated.

References
NKR; (record avelumab)
Additional comments
Het aantal patiënten dat 1e lijns systemische therapie heeft gehad voor onresectable locally advanced of synchroon gemetastaseerd voor adenocarcinoom van de maag of gastro-oesfageale overgang lag tussen 2015 en 2017 tussen de 330 en 350 patiënten per jaar. Vaak worden geneesmiddelen die initieel zijn goedgekeurd voor deze groep ook ingezet voor patiënten met adenocarcinoom van de slokdarm. Dit zou betekenen dat er in totaal ongeveer 260-290 patiënten per jaar in aanmerking komen voor deze behandeling. Er is in te schatten dat 25-30% van de patiënten voldoende expressie van CXLAUDIN heeft voor behandeling aan de hand van de aanname uit de MONO studie. Er zullen dan 75 - 100 patiënten in aanmerking komen.

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.