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
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
Portfolio holder 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 June 2023
Expected Registration June 2024
Orphan drug Yes
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening in juni 2023 en registratie in juni 2024.

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 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 CLAUDINE 18.2 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.