Triple-Negative Breast Cancer: Sacituzumab Govitecan FDA Accelerated Approval
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Novel ADC for Treatment-Resistant TNBC
- April 22, 2020
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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
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