FDA approves Trodelvy for advanced urothelial cancer
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The FDA today granted accelerated approval to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
Sacituzumab govitecan (Trodelvy; Immunomedics, Gilead Sciences) is an antibody-drug conjugate that combines an antibody to the Trop-2 antigen and releases SN-38, the metabolite of the chemotherapy drug irinotecan, directly into cancer cells of the tumor microenvironment.
The FDA based this approval, in part, on data 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 10 mg/kg IV sacituzumab govitecan on days 1 and 8 of a 21-day treatment cycle.
Objective response rate and duration of response, evaluated using RECIST version 1.1, served as the study’s primary endpoints.
Researchers reported a confirmed ORR of 27.7% (95% CI, 19.6-36.9), which included a 5.4% complete response rate and 22.3% partial response rate. Median duration of response among 31 responding patients was 7.2 months (95% CI, 4.7-8.6).
Adverse events that occurred among more than 25% of patients treated with sacituzumab govitecan included neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash and abdominal pain.
The application, reviewed under the Real-Time Oncology Review pilot program, also received priority review and fast track designations.
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