Pfizer and Astellas Pharma have received the US Food and Drug Administration (FDA) approval for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC).

The combination is said to be the first therapy approved to provide an alternative to platinum-containing chemotherapy, which is the existing standard of care in the first line of treatment of la/mUC.

The approval was based on the findings from the Phase 3 EV-302 clinical trial that assessed the combination in individuals with previously untreated la/mUC.

According to the results, the therapy nearly doubled median overall survival (OS) and median progression-free survival (PFS) in comparison to platinum-containing chemotherapy.

The study met its primary endpoints of OS and PFS compared to the chemotherapy.

The therapy also resulted in a median OS of 31.5 months against 16.1 months with chemotherapy, demonstrating a 53% reduction in death risk.

In addition, the median PFS of 12.5 months with Padcev with Keytruda combination in comparison to 6.3 months with chemotherapy shows a 55% decrease in the risk of cancer progression or death.

Pfizer oncology chief development officer Roger Dansey said: “In the Phase 3 EV-302 study, the combination of Padcev and pembrolizumab demonstrated survival benefit for patients with advanced bladder cancer, nearly doubling median OS and median PFS compared with chemotherapy.

“We hope the approval of this combination will transform the standard of care for advanced bladder cancer and give patients more time with their loved ones.”

EV-302 trial is an open-label, randomised, controlled late-stage study that enrolled 886 patients.

The key secondary endpoints include objective response rate (ORR) and duration of response (DOR), and safety.

EV-302 study also serves as the confirmatory trial for the US accelerated approval of this combination.

Astellas oncology development head and senior vice president Ahsan Arozullah said: “Today’s FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease.

“This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”