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FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer


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On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

TROPHY Trial

Efficacy and safety were evaluated in TROPHY (IMMU-132-06; ClinicalTrials.gov identifier: NCT03547973), a single-arm, multicenter trial that enrolled 112 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Patients received sacituzumab govitecan at 10 mg/kg intravenously on days 1 and 8 of a 21-day treatment cycle.

The main efficacy endpoints were objective response rate and duration of response evaluated by independent review using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The confirmed objective response rate was 27.7% (95% confidence interval [CI] = 19.6%–36.9%) with 5.4% consisting of complete responses and 22.3% of partial responses. The median duration of response was 7.2 months (n = 31; 95% CI = 4.7–8.6; range = 1.4+ to 13.7).

The most common adverse reactions (incidence > 25%) in patients receiving sacituzumab govitecan were neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.

The recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity.


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