Enfortumab Vedotin-ejfv Receives FDA Approval for Advanced Urothelial Carcinoma
Posted: Friday, July 16, 2021
On July 9, the U.S. Food and Drug Administration (FDA) approved the use of the antibody-drug conjugate enfortumab vedotin-ejfv (Padcev) and approved a new indication for adults with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. The FDA had previously granted accelerated approval for enfortumab vedotin-ejfv for the treatment of adults with locally advanced or metastatic urothelial cancer who received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before neoadjuvant or after adjuvant surgery or in a locally advanced or metastatic urothelial cancer setting.
The FDA approval was based on data from the global, multicenter, open-label phase III EV-301 trial and the multicohort, multicenter, phase II EV-201 clinical trial. The EV-301 study evaluated enfortumab vedotin-ejfv versus physician’s choice of chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who were treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
Patients given enfortumab vedotin-ejfv lived a median of 3.9 months longer than patients given chemotherapy. Additionally, the median overall survival was 12.9 months with enfortumab vedotin-ejfv compared with chemotherapy.
In cohort 2 of the EV-201 study, 89 patients with locally advanced or metastatic urothelial cancer who had not been previously treated with a PD-L1 inhibitor, had not received a platinum-containing chemotherapy, and were ineligible for cisplatin received enfortumab vedotin-ejfv. About 51% of patients given enfortumab vedotin-ejfv had an objective response, with a median duration of response of 13.8 months after a median follow-up of 16 months.
The recommended dose of enfortumab vedotin-ejfv is 1.25 mg/kg (up to a maximum dose of 125 mg) administered as an intravenous infusion over 30 minutes on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. For more prescribing information on enfortumab vedotin-ejfv, visit accessdata.fda.gov.