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

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

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

Shots:

  • 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

Click here to­ read full press release/ article | Ref: Astellas | Image:The Pharma Letter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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