FDA Expands Indication and Grants Regular Approval for Treatment of Urothelial Cancer

“The FDA’s decision to convert expedited approval to regular approval was based on data from the phase 3 trial EV-301, which had overall survival for patients treated with [enfortumab vedotin-ejfv] compared to chemotherapy, ”said Andrew Krivoshik, MD, PhD, senior vice president and head of oncology therapeutics, Astellas, in a press release. “With [enfortumab vedotin-ejfv], for the first time, doctors can treat advanced urothelial cancer after treatment with platinum-containing therapy and immunotherapy using FDA-approved therapy that has shown overall survival benefit over chemotherapy. “

According to Astellas, around 573,000 new cases of bladder cancer and more than 212,000 deaths are reported worldwide each year. Patients who are not eligible for chemotherapy containing cisplatin generally have limited treatment options and a poor prognosis.

The EV-301 trial compared fortumab vedotin-ejfv with chemotherapy in adult patients (n = 608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and PD-1 / L1 inhibitor. At the time of the pre-defined interim analysis, patients who received fortumab vedotin-ejfv (n = 301) in the trial experienced a median duration of 3.9 months longer than those who received chemotherapy ( n = 307). Median overall survival was 12.9 months versus 9.0 months, respectively [Hazard Ratio=0.70 (95% CI: 0.56, 0.89), p=0.001].

The most common (≥ 20%) all grade adverse reactions reported in trial EV-301 included rash, fatigue, peripheral neuropathy, alopecia, decreased appetite, diarrhea, pruritus , nausea, constipation, dysgeusia, musculoskeletal pain, dry eye, fever, abdominal pain and anemia.

Cohort 2 of the EV-201 trial evaluated fortumab vedotin-ejfv in patients (n = 89) with locally advanced or metastatic urothelial cancer who had previously been treated with a PD-1 / L1 inhibitor , had not received platinum-based chemotherapy in this setting, and were not eligible for cisplatin. After a median follow-up of 16 months, 51% of patients who received enfortumab vedotin-ejfv had an objective response [95% CI: 39.8, 61.3] by independent central blinded examination, with a median duration of response of 13.8 months [95% CI: 6.4, not reached].

The most common (≥ 20%) all grade adverse reactions reported in trial EV-201 included rash, peripheral neuropathy, alopecia, fatigue, decreased appetite, anemia, diarrhea, pruritus, weight loss, nausea, dry eye, and dysgeusia.

“Almost half of [patients with advanced bladder cancer] cannot receive chemotherapy with cisplatin. Many of these patients will receive first-line immunotherapy. If their cancer is not responding, or if it progresses after a previous response to immunotherapy, there is an urgent need for more treatment options as there is currently no standard of care, ”said Evan Y Yu, MD, Division of Oncology, Medicine, University of Washington School of Medicine and a principal investigator of the EV-201 trial, in a press release: “A new regulatory approval for vedotin-ejfv fortumab is a important clinical breakthrough and may help address this unmet need. “


US FDA grants regular approval and expands indication of Padcev (enfortumab vedotin-ejfv) for patients with locally advanced or metastatic urothelial cancer [news release]. July 9, 2021; Astellas. [email]

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