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Zolbetuximab

Vyloy

Extended indication

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

Therapeutic value

Possibly no place in the treatment regimen
Registration phase

Registration application pending

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

Vyloy
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)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

June 2023
Expected Registration

September 2024
Orphan drug

Yes
Registration phase

Registration application pending
Additional remarks 
Fabrikant verwacht indiening in juni 2023 en registratie in september 2024.

Therapeutic value

Current treatment options

Huidige behandelopties zijn CAPOX / mFOLFOX.
Therapeutic value

Possibly no place in the treatment regimen
Substantiation

First in class, nieuwe target therapie. Zolbetuximab Er was een reductie van overlijden ten opzichte van placebo (HR 0,75, 95% CI 0·60–0·94; p=0·0053). De paskwil-criteria zijn niet gehaald.
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 
(1) NKR; (record avelumab);  (2) A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study - PMC (nih.gov)
Additional remarks 
(1) Het aantal patiënten dat eerste lijn systemische therapie heeft gehad voor onresectable locally advanced of gemetastaseerd voor adenocarcinoom van de maag of gastro-oesofageale 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 tot 290 patiënten per jaar in aanmerking komen voor deze behandeling. (2) Volgens de aanname in MONO studie heeft 31%  van de patiënten voldoende expressie van CLAUDINE 18.2 voor behandeling. Er zullen dan 75 tot 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

Indication extension

Yes
Indication extensions

Pancreas
Additional remarks 
2026

Other information

There is currently no futher information available.