Bladder Cancer Coverage from Every Angle
Advertisement
Advertisement

Enfortumab Vedotin-ejfv Receives FDA Approval for Advanced Urothelial Carcinoma

By: JNCCN 360 Staff
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.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.