Roger Dansey, MD
The FDA has granted a priority review designation to a biologics license application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.1
The FDA previously granted enfortumab vedotin a breakthrough therapy designation in March 2018 for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy, based on the EV-101 data.
- Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer. Seattle Genetics. Published September 16, 2019. https://bit.ly/2mbJ9Ps. Accessed September 16, 2019.
- 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). doi: 10.1200/JCO.2019.37.18_suppl.LBA4505.
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