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FDA Grants Enfortumab Vedotin Breakthrough Designation for Urothelial Carcinoma

Jason M. Broderick @jasoncology
Published: Monday, Mar 26, 2018

Daniel P. Petrylak, MD

Daniel P. Petrylak, MD
The FDA has granted enfortumab vedotin a breakthrough therapy designation for patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy, according to Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate (ADC).

The ongoing, pivotal phase II EV-201 trial (NCT03219333) is exploring enfortumab vedotin in this setting, and the phase I EV-103 trial (NCT03288545) is exploring the ADC in combination with either pembrolizumab (Keytruda) or atezolizumab (Tecentriq).
Petrylak DP, Perez RP, Zhang J, et al. A phase i study of enfortumab vedotin: updated analysis of patients with metastatic urothelial cancer. J Clin Oncol 35, 2017 (suppl; abstr 106).

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