Enfortumab Vedotin Approved by European Commission for Pretreated Locally Advanced or Metastatic Urothelial Cancer

European patients with locally advanced or metastatic urothelial cancer can now receive treatment with enfortumab vedotin following treatment with a platinum-containing regimen and a PD-(L)1 inhibitor.

The European Commission has approved enfortumab vedotin (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer following previous treatment with a platinum-containing chemotherapy regimen and a PD-(L)1 inhibitor, according to a press release from developer Astellas Pharma.1

The approval was based on findings from the phase 3 EV-301 trial (NCT03474107), which evaluated the therapy in patients with previously treated locally advanced or metastatic disease.2 Treatment with enfortumab vedotin resulted in a median overall survival of 12.88 months vs 8.97 months in the chemotherapy arm (HR, 0.70; 95% CI, 0.56-0.89; P = .001). Median progression-free survival was also longer in the experimental vs the placebo arm at 5.55 months vs 3.71 months, respectively (HR, 0.62; 95% CI, 0.51-0.75; P <.001).

“The approval of enfortumab vedotin in the European Union is a significant milestone for people living with advanced urothelial cancer who have had limited treatment options and poor survival rates,” Ahsan Arozullah, MD, MPH, vice president of Medical Sciences-Oncology at Astellas, said in the press release. “We look forward to working with health authorities to ensure people living with advanced urothelial cancer can access this new treatment option as soon as possible.”

Enfortumab vedotin was previously approved by the FDA in the same patient population on July 9, 2021, based on results of the phase 3 EV-301 study.3


  1. European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer. News release. Astellas Pharma. April 13, 2022. Accessed April 14, 2022. https://bit.ly/3rrniCF
  2. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384(12):1125-1135. doi:10.1056/NEJMoa2035807
  3. FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer. News release. FDA. July 9, 2021. Accessed April 14, 2022. https://bit.ly/3hsvrln
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