Astellas - Seagen's Padcev Approved In Europe For Most Common Form Of Bladder Cancer


The European Commission has approved Astellas Pharma Inc ALPMF and Seagen Inc's SGEN Padcev (enfortumab vedotin) as monotherapy for urothelial cancer.

  • Urothelial cancer is the most common type of bladder cancer. In Europe, an estimated 204,000 people were diagnosed with urothelial cancer in 2020, and more than 67,000 died due to the disease. 
  • Enfortumab vedotin is the first antibody-drug conjugate authorized in the EU for urothelial cancer.
  • The approval covers adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor. 
  • Related: Astellas Pharma - Seagen's Enfortumab Shows 36% Pathologic Complete Response In Bladder Cancer Patients.
  • The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.
  • Patients who received enfortumab vedotin (n=301) lived a median of 3.9 months longer than those who received chemotherapy (n=307). 
  • Median OS was 12.9 vs. 9 months, respectively.
  • Price Action: SGEN shares are up 1.94% at $144.99 during the market session on the last check Wednesday.
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Posted In: BiotechNewsHealth CareGeneralBriefsEuropean Medicines Agency
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