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Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer


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TOKYO and BOTHELL, Wash., Feb. 18, 2021 /PRNewswire/  Astellas Pharma Inc. (TSE: 4503, President and CEO:  Kenji Yasukawa, Ph.D., Astellas ) and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV
® (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201 s second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin. ....

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New class of drug leads to 30% reduced risk of death for bladder cancer patients


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A new type of drug that helps target chemotherapy directly to cancer cells has been found to significantly increase survival of patients with the most common form of bladder cancer, according to results from a phase III clinical trial led in the UK by Queen Mary University of London and Barts Health NHS Trust.
The results are published in the
New England Journal of Medicine and were presented at the 2021 American Society of Clinical Oncology s Genitourinary Cancers Symposium.
Urothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra. Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually. ....

City Of London , City Of , United Kingdom , United States , Chunzhang Wu , Christof Vulsteke , John Abernethy , Mary Campbell , Enfortumab Vedotin , Thomas Powles , Nobuaki Matsubara , William Blizard , Danielp Petrylak , Queen Mary , Jonathane Rosenberg , Daniel Castellano , Jae Lyun Lee , Tom Powles , Joel Winston , Maria Matsangou , Yohann Loriot , School Of Medicine , Drug Administration , London School Of Medicine , St Bartholomew Medical College , Seagen Inc ,