Enfortumab vedotin
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Urothelial carcinoma4 | |||
None | + pembrolizumab | Neoadj. early | Muscle-invasive only; Then adjuvant enfortumab vedotin + pembrolizumab after surgery |
None | + pembrolizumab | Adj. early | Muscle-invasive only; After neoadjuvant enfortumab vedotin + pembrolizumab and radical cystectomy |
None | + pembrolizumab | 1L advanced | Eligible for platinum-containing chemotherapy |
None | Monotherapy | 2L advanced | Previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor |
Full text of section 4.1 (therapeutic indications)
Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC). Unresectable or metastatic urothelial cancer Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Locally advanced or metastatic urothelial cancer 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 (see section 5.1).
Label history
12 changes to the Padcev label since 2023, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes