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