EMA — authorised 19 September 2024
- Application: EMEA/H/C/005868
- Marketing authorisation holder: Astellas Pharma Europe B.V.
- Local brand name: Vyloy
- Indication: Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first line treatment of adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).
- Pathway: orphan
- Status: approved
On 19 September 2024, the European Medicines Agency (EMA) granted marketing authorisation for Vyloy, an orphan medicinal product, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma. Vyloy is indicated for use in combination with fluoropyrimidine- and platinum-containing chemotherapy. The marketing authorisation holder is Astellas Pharma Europe B.V.