On April 13, 2021, the FDA accelerated the approval of sacituzumab govitecan (Trodelvy; Immunomedics), a Trop-2 antibody and topoisomerase inhibitor, for patients with locally advanced or metastatic urothelial cancer who had received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA had granted sacituzumab govitecan a breakthrough therapy designation for this indication.
A week earlier, on April 7, 2021, the FDA granted sacituzumab govitecan regular approval for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received ≥2 systemic therapies, at least 1 for metastatic disease. Sacituzumab govitecan was granted an accelerated approval for TNBC in April 2020.
The FDA approval of the new indication for sacituzumab govitecan for the treatment of advanced urothelial cancer was based on results of the TROPHY study, a single-arm, multicenter clinical trial of 112 patients with locally advanced or metastatic urothelial cancer who had received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. Patients received sacituzumab govitecan, 10 mg/kg intravenously, on days 1 and 8 of a 21-day treatment cycle.
The main efficacy measures were the objective response rate (ORR) and the duration of response. The confirmed ORR was 27.7% (95% confidence interval [CI], 19.6-36.9), including 5.4% complete responses and 22.3% partial responses. The median duration of response was 7.2 months (95% CI, 4.7-8.6).
The most common (>25%) adverse reactions reported with sacituzumab govitecan were neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.
Continued approval of this indication may be contingent on the demonstration of a clinical benefit in a confirmatory clinical trial.