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FDA Approval Sought for Enfortumab Vedotin for Urothelial Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jul 16, 2019

Roger Dansey, MD, chief medical officer of Seattle Genetics

Roger Dansey, MD

A biologics license application (BLA) has been submitted to the FDA for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.1

Additionally, the ongoing EV-103 trial (NCT03288545) is evaluating enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab (Keytruda) and/or platinum chemotherapy in newly diagnosed patients as well as those whose cancer progressed from earlier-stage disease.


  1. Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer. Seattle Genetics. Published July 16, 2019. Accessed July 16, 2019.
  2. 2. Petrylak DP, Balar AV, O'Donnell PH, et al. EV-201: results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors. J Clin Oncol. 2019;37(suppl; abstr LBA4505).

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