Shots:

• The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV's accelerated approval to regular approval
• The second sBLA is based on cohort 2 of the P-II EV-201 trial evaluating Padcev in 91 patients with LA or mUC who have been previously treated with PD-1 or PD-L1 inhibitor and are ineligible for cisplatin. It requests an expansion of the current indication
• The submissions will be reviewed under Project Orbis for both the trials and results were presented at ASCO GU’ 2021. The target action date for both applications is Aug 17- 2021

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