FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial Cancer

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.