Sacituzumab Govitecan-hziy Granted Accelerated Approval for Advanced Urothelial Carcinoma
Posted: Wednesday, April 14, 2021
On April 13, the U.S. Food and Drug Administration (FDA) gave accelerated approval to the PD-L1 inhibitor sacituzumab govitecan-hziy (Trodelvy) for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. The accelerated approval is the second FDA approval for sacituzumab govitecan. The PD-L1 inhibitor is also approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had two or more prior systemic therapies, at least one of them for metastatic disease.
The FDA approval was based on the efficacy and safety results from the international, phase II single-arm TROPHY study. The multicenter trial enrolled 112 patients with locally advanced or metastatic urothelial carcinoma who had a treatment history of platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor. Patients were administered 10 mg/kg of sacituzumab govitecan intravenously on days 1 and 8 of a 21-day treatment cycle.
Results showed an overall response rate of 27.7% for sacituzumab govitecan, with 5.4% being complete responses and 22.3% being partial responses. The median duration of response was 7.2 months.
The most common adverse reactions observed in more than 25% of patients administered sacituzumab govitecan included neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain. Adverse reactions leading to treatment discontinuation occurred in 10% of patients. About 4% of patients discontinued treatment due to neutropenia.
The recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity. Full prescribing information is available at accessdata.fda.gov.