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Enfortumab vedotin Approval Status

FDA Approved: No
Generic name: enfortumab vedotin
Company: Astellas and Seattle Genetics
Treatment for: Urothelial Carcinoma

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

Development Status and FDA Approval Process for enfortumab vedotin

DateArticle
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

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