FDA grant Priority Review for nivolumab for adjuvant treatment for muscle-invasive urothelial carcinoma

Priority review was granted on the basis of the Phase 3 CheckMate -274 trial (n=709), where nivolumab significantly increased disease-free survival vs placebo regardless of PD-L1 expression (21.0 vs 10.9 months). Recurrence free survival was 24.6 vs 13.7 months respectively.

Source:

Biospace Inc.