FDA Cancer Treatment Approvals in June and July 2021

In June and July, the United States Food and Drug Administration (FDA) granted several new and expanded drug indications for the treatment of patients with cancer.

  • Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer. The accelerated approval for enfortumab vedotin (Padcev®, Astellas Pharma US, Inc.), an antibody–drug conjugate targeting nectin-4, has been changed to regular approval for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) who have either previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received ≥1 lines of therapy. The clinical benefit of EV was confirmed in the open-label, randomized, multicenter, phase III Trial EV-301, where overall survival (OS) was significantly prolonged with EV compared with standard chemotherapy in patients with locally advanced or metastatic UC who had previously received platinum-based treatment and a PD-1 or PD-L1 inhibitor (12.9 versus 9.0 months; hazard ratio [HR] 0.70; P=0.0014). Median progression-free survival (PFS) was 5.6 versus 3.7 months, respectively (HR 0.62; P<0.0001) and the overall response rate (ORR) more than doubled with EV (40.6% versus 17.9%; P<0.0001). For patients who have received a prior PD-1 or PD-L1 inhibitor and are ineligible for cisplatin-containing chemotherapy, efficacy was evaluated in Cohort 2 of the single-arm, multi-cohort, international EV-201 trial. Confirmed ORR by blinded independent central review (BICR) was 52%, including 20% complete response (CR), and median duration of response (DoR) was 10.9 months.