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Padcev FDA Approval History

FDA Approved: Yes (First approved December 18, 2019)
Brand name: Padcev
Generic name: enfortumab vedotin-ejfv
Dosage form: for Injection
Company: Astellas and Seattle Genetics
Treatment for: Urothelial Carcinoma

Padcev (enfortumab vedotin-ejfv) is a Nectin-4 targeted antibody-drug conjugate (ADC) for the treatment of patients with locally advanced or metastatic urothelial cancer.

Development Timeline for Padcev

DateArticle
Dec 18, 2019Approval  FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
Sep 28, 2019Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer
Jul 16, 2019Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Jun  3, 2019Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer
Mar 28, 2019Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
Jun  3, 2018Astellas and Seattle Genetics Present at ASCO 2018 on Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Cancer Previously Treated with Checkpoint Inhibitor Therapy

Further information

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