FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) to treat adult patients with locally advanced or metastatic urothelial cancer (mUC), who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. 

With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with mUC, the most common type of bladder cancer.

This new indication marks the second FDA approval for Trodelvy, following the full approval granted last week for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The approval of sacituzumab govitecan was based on the phase 2, single-arm TROPHY-U-01 trial, which enrolled 112 patients with locally advanced or mUC who received prior treatment with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Study participants received sacituzumab govitecan, 10 mg/kg intravenously, on days 1 and 8 of a 21-day treatment cycle.

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

The most common (≥25%) adverse reactions associated with sacituzumab govitecan include neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.

Of note, the recommended dosage of Sacituzumab govitecan is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity. –Alexis Hyams

Source: US Food and Drug Administration. FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. April 13, 2021.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer. Accessed April 13, 2021.