Shots:

• The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC- prior treated with platinum-based CT and PD-1/L1 inhibitor
• The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC- prior treated with PD-1/L1 inhibitor- including those who have been treated with a Pt.-containing CT (cohort 1) and those who have not received a Pt. containing CT and are ineligible for cisplatin (cohort 2).
• Both the studies met their 1EPs of OS & ORR. If approved- Enfortumab Vedotin will be the 1st ADC available in Japan for people living with UC

 ­ Ref: PRNewswire | Image: Astellas