FDA Grants Accelerated Approval to Trodelvy for Advanced Bladder Cancer


Trodelvy has received accelerated approval from the FDA for the treatment of patients with advanced urothelial cancer.

The Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Trodelvy (sacituzumab govitecan) for patients with locally advanced or metastatic urothelial cancer, who in the past have received platinum chemotherapy and either a programmed death recptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

This approval comes following the results of a single arm, multicenter trial, TROPHY, which enrolled 112 patients with locally advanced or metastatic urothelial cancer and had received prior treatment with platinum chemotherapy and either PD-1 or PD-L1. Patients received Trodelvy at 10 milligrams (mg) intravenously on days one and eight of a 21-day cycle. The FDA recommends this treatment regimen until a patient’s disease progresses or they experience unacceptable toxicities.

The main goal of the TROPHY trial was to evaluate the objective response rate (the proportion of patients who had a complete or partial response to treatment) and duration of response (time from response to disease progression or death) associated with Trodelvy. The confirmed objective response rate was 27.7%, which included 5.4% complete responses and 22.3% partial responses. Moreover, median duration of response was 7.2 months.

The most common side effects (greater than 25% incidence) that occurred in patients who received Trodelvy included neutropenia, nausea, diarrhea, fatigue, alopecia (sudden and patchy hair loss), anemia (low red blood cell count), vomiting, constipation, lowered appetite, rash and abdominal pain.

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