Full Approval for a Bladder Cancer Treatment
Enfortumab vedotin-ejfv plus pembrolizumab was approved for certain bladder cancers.
The U.S. Food and Drug Administration (FDA) has approved enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer.
This regimen was granted an accelerated approval in April 2023 for patients with locally advanced or metastatic urothelial cancer who are ineligible for certain chemotherapies.
Enfortumab vedotin-ejfv is an antibody-drug conjugate, a type of targeted therapy that combines a tumor-seeking antibody with a toxic drug. The antibody part of enfortumab vedotin-ejfv seeks out the nectin-4 protein, which is found on the surface of most bladder cancer cells. Upon binding nectin-4, the toxic drug is released into the cell, ultimately killing it. Pembrolizumab is an immunotherapy that helps prevent cancers from suppressing antitumor immune responses.
The conversion of the accelerated approval to a full approval was based on results from the open-label, randomized EV-302/KN-A39 phase III clinical trial, which evaluated overall and progression-free survival in 886 patients with locally advanced or metastatic urothelial cancer who had not received prior systemic therapy for advanced disease. Patients were randomly assigned (1:1) to receive chemotherapy or enfortumab vedotin-ejfv plus pembrolizumab.
Patients in the enfortumab vedotin-ejfv plus pembrolizumab arm had a significantly longer median overall survival than those in the chemotherapy arm (31.5 months vs. 16.1 months). Patients treated with the enfortumab vedotin-ejfv and pembrolizumab combination also had a significantly longer median progression-free survival than those treated with chemotherapy (12.5 months vs. 6.3 months).
Urothelial cancer is the most common type of bladder cancer. According to federal statistics, it was estimated that 82,290 individuals would be diagnosed with bladder cancer and 16,710 patients would die of the disease in the United States in 2023.
The FDA rendered its decision on December 15, 2023.
