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).

Rashes, aspartate aminotransferase increased, glucose increased, creatinine increased, fatigue, peripheral neuropathy, lymphocytes decreased, alopecia, decreased appetite, haemoglobin decreased, diarrhoea, sodium decreased, nausea, pruritus, phosphate decreased, dysgeusia, alanine aminotransferase increased, anaemia, anaemia, anaemia, anaemia, anaemia, ane

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.

Reference: https://www.fda.gov/

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