Urothelial Carcinoma: Sacituzumab Govitecan FDA Approval

FDA Accelerated Approval

• April 23, 2021

On April 13, 2021, the FDA granted accelerated approval for sacituzumab govitecan (Trodelvy) in previously treated (platinum-based and checkpoint inhibitor therapy) locally advanced or metastatic urothelial carcinoma.

TROPHY-U01 Trial Design

Patient Population: Previously treated (platinum + PD-1/PD-L1) locally advanced or metastatic urothelial cancer (n=112)

Treatment: Sacituzumab govitecan 10 mg/kg IV on Days 1 and 8 of each 21-day cycle

Primary Endpoints: Objective response rate, response duration

Key Efficacy Results

Objective Response Rate: 27.7%

• Complete response: 5.4%
• Partial response: 22.3%

Median Response Duration: 7.2 months

Safety Profile

Most Common Adverse Events (≥25%):

• Neutropenia
• Nausea
• Diarrhea
• Fatigue
• Alopecia
• Anemia
• Vomiting
• Constipation
• Anorexia
• Rash
• Abdominal pain

Dosing and Administration

Recommended Dose: 10 mg/kg IV on Days 1 and 8 of each 21-day cycle (Day 15 rest)

Treatment Continues: Until disease progression or unmanageable toxicity

Clinical Significance

Sacituzumab govitecan provides therapeutic option for platinum and checkpoint inhibitor-refractory urothelial carcinoma with meaningful response rates.

Data Source

FDA Approval Notice: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer

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