VYLOY (Astellas Pharma Australia Pty Ltd)
Product name
VYLOY
Date registered
Evaluation commenced
Decision date
Approval time
230 (255 working days)
Active ingredients
zolbetuximab
Registration type
NCE/ NBE
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 human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GOJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2 Dose and method of administration).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.