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FDA Approves Enfortumab Vedotin for Urothelial Cancer

OncLive Staff
Published: Wednesday, Dec 18, 2019

The FDA granted an accelerated approval to enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.

The accelerated approval of enfortumab vedotin in this setting is contingent on the results of a confirmatory trial.

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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