The FDA has given enfortumab vedotin-ejfv approval for the treatment of locally advanced or metastatic urothelial carcinoma

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August 2021: Enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor combination, has been approved by the Food and Drug Administration for adult patients with locally advanced or metastatic urothelial carcinoma.

have previously received a programmed death receptor-1 (PD-1) or programmed death ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or have previously had one or more prior lines of therapy and are ineligible for cisplatin-containing chemotherapy
In December 2019, the FDA granted enfortumab vedotin-ejfv accelerated approval for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The open-label, randomised, multicenter trial EV-301 (NCT03474107) was necessary to confirm the clinical benefit of the 2019 accelerated authorisation. 608 individuals with locally advanced or metastatic urothelial carcinoma who had previously undergone a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy were enrolled in this study. On days 1, 8, and 15 of a 28-day cycle, patients were randomised (1:1) to receive either enfortumab vedotin-ejfv (EV) 1.25 mg/kg or the investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine).

Overall survival (OS) was the primary effectiveness outcome, with progression-free survival (PFS) and overall response rate (ORR) being critical secondary efficacy endpoints assessed by investigators using RECIST 1.1. Patients on the EV arm (n=301) had a median OS of 12.9 months (95 percent CI: 10.6, 15.2) compared to 9.0 months (95 percent CI: 8.1, 10.7) in the chemotherapy arm (n=307) (HR 0.70; 95 percent CI: 0.56, 0.89; p=0.0014). The median PFS was 5.6 months (95 percent confidence interval: 5.3, 5.8) versus 3.7 months (95 percent confidence interval: 3.5, 3.9), respectively (HR 0.62; 95 percent confidence interval: 0.51, 0.75; p0.0001). The ORR was 40.6 percent (95 percent confidence interval: 34.9, 46.5) versus 17.9 percent (95 percent confidence interval: 13.7, 22.8) (p0.0001).

Efficacy in 89 patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L1 inhibitor and were ineligible for cisplatin-containing chemotherapy was evaluated in Cohort 2 of EV-201 (NCT03219333), a single-arm, multi-cohort, international trial in 89 patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L The primary efficacy outcome was confirmed ORR, which was assessed by a blinded independent central review, and response length was a key secondary efficacy endpoint. The confirmed ORR was 51% (95 percent CI: 39.8, 61.3), with 22% of replies being complete, and the median response time was 13.8 months (95 percent CI: 6.4, not estimable).

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The USPI now includes a boxed warning for significant skin reactions, such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, as well as a warning for pneumonitis.


Enfortumab vedotin-ejfv is given as an intravenous infusion lasting 30 minutes on days 1, 8, and 15 of a 28-day cycle until disease progression or intolerable toxicity.


Check details here.


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