Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots:

  • The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS
  • The second BLA submission is based on P-II cohort 2 of EV-201 trial which involves assessing of Padcev in 128 patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but not eligible for cisplatin. The 1EP’s study was ORR
  • The submissions will be reviewed under RTOR for both the trials and results were presented at the ASCO GU’ 2021

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

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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