Zolbetuximab (2) – Vyloy®

Name: Frühe Nutzenbewertungen nach § 35a SGB V
Creator: Gemeinsamer Bundesausschuss

Adenocarcinoma of the stomach or the gastro-oesophageal junction, HER2-negative, first-line treatment, combination with fluoropyrimidine- and platinum-based chemotherapy

Start date	15.05.2026
Resolution	05.11.2026 – active procedure
INN	Zolbetuximab
Brand name	Vyloy®
Pharm. company	Astellas Pharma GmbH
G-BA Procedure ID	D-1329
Therapeutic area	Oncological diseases Orphan (turnover limit)
Reason for procedure	Reassessment: Orphan turnover exceeded

active procedures repealed resolutions


15.05.2026	05.11.2026	Zolbetuximab (2)	Vyloy®	Astellas Pharma GmbH	Oncological diseases	Adenocarcinoma of the stomach or the gastro-oesophageal junction, HER2-negative, first-line treatment, combination with fluoropyrimidine- and platinum-based chemotherapy	n.d.	active procedure Orphan (turnover limit)
01.11.2024	17.04.2025	Zolbetuximab (1)	Vyloy®	Astellas Pharma GmbH	Oncological diseases	Adenocarcinoma of the stomach or gastro-oesophageal junction, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-containing chemotherapy	250–1,310	100% Indication of minor additional benefit Orphan

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