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Seattle Genetics and Astellas Report Acceptance of BLA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

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Seattle Genetics and Astellas Report Acceptance of BLA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

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  • The BLA submission is based on EV-201 P-II clinical study assessing Enfortumab Vedotin in patients with LA/m- urothelial cancer prior treated with PD-1/L1 inhibitor- including patients treated/not treated with platinum-containing CT ineligible for cisplatin
  • The US FDA has granted Priority Review to the BLA which is a milestone toward offering a new therapy to the patients with advanced urothelial cancer and unmet medical needs
  • Enfortumab Vedotin is an investigational ADC comprising of an anti-Nectin-4 mAb- attached to MMAE utilizing Seattle Genetics' technology and has received FDA’s BT designation in Mar’2018 with its PDUFA date as Mar 15- 2020

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Ref: Astellas | Image:Astellas


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