Enfortumab Vedotin Receives FDA Approval for Locally Advanced or Metastatic Urothelial Cancer

Enfortumab vedotin-ejfv is the first FDA-approved treatment in the United States for this patient population.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Seattle Genetics, Inc) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before neoadjuvant or after adjuvant surgery or in a locally advanced or metastatic setting.

Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Enfortumab vedotin-ejfv is the first FDA-approved treatment in the United States for this patient population and is a first-in-class antibody-drug conjugate that is directed against nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

“Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options, and the approval of Padcev is a significant advance for these patients who previously had limited options after initial therapies failed,” said Jonathan E. Rosenberg, MD, medical oncologist, chief, Genitourinary Medical Oncology Service, Memorial Sloan Kettering Cancer Center in New York. “The Padcev clinical trial enrolled a range of patients whose cancer was difficult to treat, including those whose disease had spread to the liver.”

Enfortumab vedotin-ejfv was evaluated in the pivotal trial EV-201, a single-arm phase 2 multi-center trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy.

In the study, the primary endpoint of confirmed objective response rate was 44% per blinded independent central review. Among patients treated with the single agent enfortumab vedotin-ejfv, 12% experienced a complete response, meaning no cancer could be detected at the time of assessment and 32% experienced a partial response.

The most common adverse events were urinary tract infection, cellulitis, febrile neutropenia, diarrhea, sepsis, acute kidney injury, dyspnea, and rash.


FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer [press release]. Published December 18, 2019. https://www.businesswire.com/news/home/20191218005817/en/FDA-Grants-Accelerated-Approval-Astellas%E2%80%99-Seattle-Genetics%E2%80%99. Accessed December 19, 2019.

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