Durvalumab (Imfinzi) + enfortumab vedotin-ejfv approved by the US FDA for muscle-invasive bladder cancer (MIBC)
FDAApproved
Durvalumab (Imfinzi) with enfortumab vedotin-ejfv
Adults with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy: neoadjuvant durvalumab + enfortumab vedotin-ejfv, then adjuvant durvalumab after radical cystectomy
0.51
Hazard ratio, event-free survival
95% CI 0.38–0.67; p<0.0001. Median EFS not reached vs 12.1 months
0.58
Hazard ratio, overall survival
95% CI 0.40–0.83; p=0.0027. Median OS not reached in either arm
Take-home
A meaningful new option for patients who cannot receive or decline cisplatin.
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