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Sacituzumab govitecan receives fast approval from the FDA for advanced urothelial cancer

August 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) was given accelerated approval by the Food and Drug Administration for patients with locally advanced or metastatic urothelial cancer (mUC) who had previously received platinum-based chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death ligand 1 (PD-L1) inhibitor.

TROPHY (IMMU-132-06; NCT03547973) was a single-arm, multicenter trial that enrolled 112 patients with locally advanced or metastatic UC who had previously received platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor. On days 1 and 8 of a 21-day therapy cycle, patients received 10 mg/kg sacituzumab govitecan intravenously.

The major efficacy outcomes were the objective response rate (ORR) and duration of response (DOR), which were assessed using RECIST 1.1 criteria by an independent review. With 5.4 percent complete responses and 22.3 percent partial responses, the confirmed ORR was 27.7% (95 percent CI: 19.6, 36.9). The median DOR (n=31; 95 percent CI: 4.7, 8.6; range 1.4+, 13.7) was 7.2 months.

Neutropenia, nausea, diarrhoea, lethargy, alopecia, anaemia, vomiting, constipation, decreased appetite, rash, and stomach discomfort are the most prevalent side events (incidence >25%) in patients taking sacituzumab govitecan.

Until disease progression or intolerable toxicity, the recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day therapy cycles.

 

Reference : https://www.fda.gov/

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  • August 25th, 2021

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