FDA to Evaluate BLAs for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

Article

Two supplemental BLAs have been submitted to the FDA for enfortumab vedotin-ejfv to convert its accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer.

Two supplemental biologics license applications have been submitted to the FDA for enfortumab vedotin-ejfv to convert the agent’s accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer who had received prior treatment with a PD-1/PD-L1 inhibitor and are not eligible for cisplatin.1 The first application is based on data from the phase 3 EV-301 trial (NCT033474107), in which the antibody-drug conjugate (ADC) demonstrated superior efficacy and a survival advantage over chemotherapy in this patient population.

The median overall survival (OS) with enfortumab vedotin was 12.88 months (95% CI, 10.58-15.21) versus 8.97 months (95% CI, 8.05-10.74) with chemotherapy (HR, 0.70; 95% CI, 0.56-0.89; P = .00142).2 The second application is based on findings from the second cohort of the phase 2 EV-201 trial (NCT032193333), where the ADC was found to elicit the highest response rates observed for any regimen examined in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who previously received PD-1/PD-L1 inhibitors.3 The confirmed objective response rate (ORR) achieved with enfortumab vedotin was 52% (95% CI, 40.8%-62.4%)

“The FDA’s review of our applications under Real-Time Oncology Review supports our efforts to expand [enfortumab vedotin]’s availability as a treatment option for more patients as quickly as possible,” Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic head of Astellas, stated in a press release. “Locally advanced or metastatic urothelial cancer is an aggressive disease with limited therapeutic options.”

In December 2019, the FDA granted an accelerated approval to enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.

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