Triple-Negative Breast Cancer: Sacituzumab Govitecan FDA Accelerated Approval

Novel ADC for Treatment-Resistant TNBC

• April 22, 2020
• Reading time: 1 minute

On April 22, 2020, the U.S. Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy) for metastatic triple-negative breast cancer patients who have received at least two prior systemic therapies.

IMMU-132-01 Trial Design

Patient Population: 108 heavily pretreated metastatic triple-negative breast cancer patients

Treatment Regimen:

• Sacituzumab govitecan 10 mg/kg IV
• Day 1 and Day 8
• 21-day treatment cycles
• Tumor imaging reassessment every 8 weeks

Clinical Efficacy Results

Objective Response Rate: 33.3%

Median Duration of Response: 7.7 months

These outcomes in a heavily pretreated population demonstrated meaningful clinical benefit supporting accelerated approval pathway.

Safety Profile

Most Common Adverse Events (≥25%):

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

Serious Toxicities: Severe neutropenia and diarrhea reported; require clinical monitoring

Recommended Dosing

Standard Regimen:

• Sacituzumab govitecan 10 mg/kg IV
• Days 1 and 8 of 21-day cycle
• Continue until disease progression or unacceptable toxicity

Clinical Significance

FDA accelerated approval establishes sacituzumab govitecan as a novel antibody-drug conjugate option for metastatic triple-negative breast cancer patients with limited prior treatment options.

Data Source

https://www.cancerit.jp/65409.html

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).

Figure 1