“The FDA’s filing of the application for enfortumab vedotin and granting of Priority Review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.“If approved, enfortumab vedotin will likely play an important role in the treatment of advanced urothelial cancer, and we look forward to working with the FDA as the review process advances,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.
Reference:
1. Astellas Pharma Global Development, Inc. Bladder Cancer (2019).
Inc., Astellas. 2019. "Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer". Prnewswire.com. https://www.prnewswire.com/news-releases/seattle-genetics-and-astellas-announce-us-fda-grants-priority-review-for-enfortumab-vedotin-biologics-license-application-in-locally-advanced-or-metastatic-urothelial-cancer-300918452.html.
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EV-201: Results of Enfortumab Vedotin Monotherapy for Locally Advanced or Metastatic Urothelial Cancer Previously Treated with Platinum and Immune Checkpoint Inhibitors - Medical Oncologist Perspective