Vyloy (zolbetuximab)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- zolbetuximab
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Stomach Neoplasms; Esophageal Neoplasms
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005868
- ATC
- L01FX31
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.