FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial Cancer

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The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

The approval is based off findings from the single-arm TROPHY (IMMU-132-06; NCT03547973) trial, which involved 112 patients with mUC who received 10 mg/kg of intravenous sacituzumab govitecan — the recommended dose — on days 1 and 8 of 21-day treatment cycles.

Overall response rate (ORR) in the trial was 27.7%, with 5.4% complete responses and 22.3% partial response. Average duration of response (DOR) was 7.2 months in the 31 patients who responded to therapy (range, 1.4+13.7).

Common adverse events from sacituzumab govitecan, which occurred in more than 25% of patients, were neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.

The FDA recommends sacituzumab govitecan be given until disease progression or unacceptable toxicity.

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