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2 Information about zolbetuximab

Marketing authorisation indication

2.1

Zolbetuximab (Vyloy, Astellas) in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for 'the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive'.

Price

2.3

The list price of zolbetuximab is £410 per 100-mg vial (excluding VAT; company submission).

2.4

The company has a commercial arrangement, which would have applied if zolbetuximab had been recommended.