The FDA expanded indications for sacituzumab govitecan-hziy (Trodelvy) with an accelerated approval for previously treated advanced bladder cancer.
The conditional approval pertains to patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-containing chemotherapy and a PD-1/L1 inhibitor. The approval makes sacituzumab govitecan the first drug with a third-line indication for advanced bladder cancer.
“Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies,” said Scott T. Tagawa, MD, of Weill Cornell Medicine in New York City, in a statement from Gilead Sciences. “The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”
The bladder cancer indication comes just a week after the FDA granted full approval of sacituzumab govitecan for unresectable or metastatic triple-negative breast cancer.
Supporting evidence for the bladder cancer indication came from the phase II, multicenter, single-arm TROPHY U-01 trial. The study involved 112 patients with locally advanced/metastatic urothelial cancer that progressed during or after treatment with platinum-based chemotherapy and a PD-1/L1 inhibitor. The primary efficacy endpoints were objective response rate (ORR) and duration of response (DOR).
The results showed an ORR of 27.7%, including complete responses in 5.4% of patients. Median DOR was 7.2 months.
The most common (>25% of patients) adverse reactions associated with sacituzumab govitecan were neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain. The FDA required a boxed warning about the risk of severe or life-threatening neutropenia and a risk of severe diarrhea.
Full approval remains contingent on additional clinical data supporting the safety and efficacy of the drug in previously treated locally advanced/metastatic urothelial carcinoma.