PADCEV (Astellas Pharma Australia Pty Ltd)
Product name
PADCEV
Date registered
Evaluation commenced
Decision date
Approval time
215 (255 working days)
Active ingredients
enfortumab vedotin
Registration type
EOI
Indication
PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).
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.