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FDA Grants Enfortumab Vedotin Priority Review for Urothelial Cancer

Gina Columbus
Published: Monday, Sep 16, 2019

Roger Dansey, MD, chief medical officer of Seattle Genetics

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.

References

  1. 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.
  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). doi: 10.1200/JCO.2019.37.18_suppl.LBA4505.

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