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# 2 Padcev sBLAs Submitted to FDA
- URL: https://www.fdaweb.com/2-padcev-sblas-submitted-to-fda/
- Published: 2021-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:47:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148701

Astellas and Seagen say they have completed submitting two sBLAs for Padcev (enfortumab vedotin-ejfv). The companies [say](https://www.marketwatch.com/press-release/astellas-and-seagen-announce-submission-of-two-supplemental-biologics-license-applications-to-the-us-fda-for-padcev-enfortumab-vedotin-ejfv-in-locally-advanced-or-metastatic-urothelial-cancer-2021-02-18?tesla=y&ref=fdaweb.com) that one submission, based on the Phase 3 EV-301 trial, seeks to convert Padcev’s accelerated approval to regular approval.

The second submission, based on the pivotal trial EV-201’s second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin, they say.

FDA is reviewing both applications under the Real-Tim e Oncology Review pilot program that aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. 

The sBLA for regular approval of Padcev is supported by data from the global EV-301 Phase 3 confirmatory trial that compared it to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The trial's primary endpoint was the overall survival of patients treated with Padcev versus chemotherapy.

The companies say the second submission, for a label expansion in the U.S., is based on results from the second cohort of EV-201, a pivotal Phase 2 clinical trial evaluating Paadcev in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The trial's primary endpoint was objective response rate.

In 2019 Padcev received accelerated approval from FDA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery in a locally advanced or metastatic urothelial cancer setting.