Extended indication previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction,
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Domvanalimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma
Manufacturer Arcus
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: A humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the co-inhibitory molecule and immune checkpoint inhibitor T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains (TIGIT), with potential immune checkpoint inhibitory activity.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op dit moment loopt de studie nog.
Frequency of administration 1 times every 3 weeks
References NCT05568095

Expected patient volume per year

Patient volume

< 532

Market share is generally not included unless otherwise stated.

References NKR2021 (1);
Additional remarks De incidentie van maagcarcinoom betrof 1.109 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt ervan uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Dit is echter significant lager dan het gedeelte met maagcarcinoom.

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 Zie indicatie-uitbreiding voor NSCLC die opgenomen is op de Horizonscan
References AdisInsight

Other information

There is currently no futher information available.