Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan

March 12, 2021 Auto Bot Advanced, Astellas, Japan, Metastatic, MHLW, NDA, regulatory, reports, Submission, Treatment, Urothelial Cancer 0

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Amwal Al Ghad

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