Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

February 19, 2021 Auto Bot FDA, Metastatic, regulatory, reports, Submission, Urothelial Cancer 0

Shots:

  • The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS
  • The second BLA submission is based on P-II cohort 2 of EV-201 trial which involves assessing of Padcev in 128 patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but not eligible for cisplatin. The 1EP’s study was ORR
  • The submissions will be reviewed under RTOR for both the trials and results were presented at the ASCO GU’ 2021

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