PADCEV (Astellas Pharma Australia Pty Ltd)
Product name
PADCEV
Date registered
Evaluation commenced
Decision date
Approval time
240 (255 working days)
Active ingredients
enfortumab vedotin
Registration type
NCE/NBE
Indication
PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand-1 inhibitor.