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U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer drugs
July 16, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted Padcev (enfortumab vedotin-ejfv) regular approval in the U.S.
Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer americanpharmaceuticalreview
April 20, 2021
Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration (FDA) filed two supplemental Biologics License Application (sBLA) submissions for PADCEV® (enfortumab vedotin-ejfv) for review as part of the ...
Astellas, Seagen Submit sBLAs for PADCEV for Urothelial Cancer americanpharmaceuticalreview
February 24, 2021
Astellas Pharma and Seagen 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).
Astellas, Seagen Announce PADCEV Trial Results for Urothelial Cancer americanpharmaceuticalreview
February 18, 2021
Astellas Pharma and Seagen announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with ...
PADCEV succeeds in confirmatory phase 3 trial in urothelial cancer pharmaceutical-business-review
September 23, 2020
Seattle Genetics and Astellas Pharma said that PADCEV (enfortumab vedotin-ejfv) met the primary endpoint of overall survival (OS) in a confirmatory phase 3 trial in previously treated locally advanced or metastatic urothelial cancer.
FDA Approves New Drug, PADCEV to Treat Locally Advanced or Metastatic Urothelial Cancer Lin Zhang
January 03, 2020
A new drug, PADCEV (enfortumab vedotin-ejfv) to treat patients with locally advanced or metastatic urothelial cancer, was approved under the FDA’s Accelerated Approval Program based on tumor response rate.
FDA approves Astellas-Seattle Genetics’ bladder cancer drug pharmaceutical-technology
December 23, 2019
The US Food and Drug Administration (FDA) has granted accelerated approval to Astellas Pharma and Seattle Genetics’ Padcev drug to treat locally advanced or metastatic urothelial cancer.
FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer drugs
December 20, 2019
Astellas Pharma Inc. and Seattle Genetics, Inc. (Nasdaq:SGEN) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev™ for the treatment of ...