On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA granted sacituzumab govitecan priority review and a fast-track designation for this indication.
The FDA approved this indication based in part on results from the single-arm, multicenter TROPHY trial, which included 112 patients with locally advanced or metastatic urothelial carcinoma who previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Patients received intravenous sacituzumab govitecan 10 mg/kg on days 1 and 8 of a 21-day treatment cycle.
The confirmed ORR was 27.7% (95% CI, 19.6-36.9), which included a 5.4% complete response rate and 22.3% partial response rate. The median duration of response among 31 responding patients was 7.2 months (95% CI, 4.7-8.6).
“Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies,” said Scott T. Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medical Center and principal investigator of the study, in a press release. “The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”
The most common (≥25%) adverse reactions among patients treated with sacituzumab govitecan included neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.
Sacituzumab govitecan was granted accelerated approval on April 22, 2020, for the treatment of patients with metastatic triple-negative breast cancer who have received ≥2 previous therapies for metastatic disease. On April 7, 2021, the FDA granted full approval for this indication.