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Padcev FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2021.

FDA Approved: Yes (First approved December 18, 2019)
Brand name: Padcev
Generic name: enfortumab vedotin-ejfv
Dosage form: Lyophilized Powder for Injection
Company: Astellas Pharma US, Inc.
Treatment for: Urothelial Carcinoma

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

  • Padcev is indicated for use in patients who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
  • Padcev is administered via intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
  • The Padcev product label carries a boxed warning for severe and fatal skin adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Padcev can cause serious adverse reactions including hyperglycemia, pneumonitis, peripheral neuropathy, ocular disorders including vision changes, infusion site reactions, and fetal harm.
  • Common adverse reactions include, skin rash, changes in liver and kidney function tests, increased blood glucose, fatigue, peripheral neuropathy, decreased white blood cell, red blood cell, and platelet counts, alopecia, decreased appetite, diarrhea, decreased sodium, phosphate and protein (albumin) in the blood, nausea, pruritus, change in sense of taste, increased uric acid in the blood, anemia, increased lipase, decreased weight, and dry skin.

Development Timeline for Padcev

DateArticle
Jul  9, 2021Approval  U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer
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
Mar 26, 2018Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
Nov  8, 2017Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer
Jun  5, 2017Seattle Genetics and Astellas Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.