The antibody-conjugate is also approved as a treatment for metastatic triple negative breast cancer.
Gilead’s Trodelvy (sacituzumab govitecan-hziy) was granted accelerated approval for the treatment of locally advanced or metastatic urothelial cancer that cannot be removed by surgery in patients that have received platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor.
The FDA’s go-ahead marks the second FDA approval for Trodelvy; it is also indicated as a treatment for metastatic triple-negative breast cancer. Trodelvy is a novel first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, which is a protein commonly found in metastatic urothelial cancer. Trodelvy attaches to the Trop-2 protein and delivers the drug directly into the cancer cells.
According to the American Cancer Society, approximately 83,000 individuals in the U.S. will be diagnosed with bladder cancer in 2021.
In a press release, Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, says that the “cases of urothelial cancer continue to rise in the U.S., yet prognosis remains the same for the vast majority of patients.”
The FDA’s accelerated approval decision was based on the results from the ongoing phase 2 TROPHY-U-01 trial, which showed that of the 112 patients evaluated for efficacy, 27.7% responded to treatment with 5.4% experiencing a complete response and 22.3% a partial response.The median duration of response was 7.2 months. The most commonly reported adverse effects inclouded diarrhea, fatigue, neutropenia, nausea, alopecia, anemia, decreased appetite, constipation, vomiting, and abdominal pain.
The TROPiCS-04 phase 3 randomized controlled trial is currently underway as a confirmatory study to ensure the safety and efficacy of Trodelvy for metastatic urothelial cancer, with an estimated enrollment of 600 participants across 123 global sites.Additionally, the primary outcome is overall survival with a study duration up to 3.5 years.
Trodelvy is administered at a dose of 10 mg/kg as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles.
It is important to note that Trodelvy carries a Boxed Warning for severe neutropenia and diarrhea. Healthcare providers should monitor blood cell counts, and patients should report any signs of infection (e.g. fever, chills, cough, shortness of breath, burning or pain during urination) and diarrhea that results in dehydration, black or bloody stools, or lasts over 24 hours.