Urothelial Carcinoma: Sacituzumab Govitecan FDA Approval
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
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
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free; an advisor will help you clarify the next steps.
Figure 1
Figure 2
Figure 3
Figure 4