Trodelvy 180 mg Vial
Brand Name: Trodelvy
Molecule: Sacituzumab Govitecan
Strength: 180 mg
Quantity: 1 Vial
Form: Injection
Packaging Type: Vial
Manufacturer/Marketed By: Gilead
Country of Origin: USA
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Description
Trodelvy 180 mg Vial contains Sacituzumab Govitecan, an advanced targeted cancer therapy classified as an antibody-drug conjugate (ADC). It is primarily used for the treatment of advanced or metastatic breast cancer, especially in patients who have already received multiple prior treatments. This medicine combines a monoclonal antibody with a chemotherapy agent, allowing it to specifically target cancer cells while minimizing damage to healthy cells. Trodelvy binds to a protein called Trop-2, which is commonly overexpressed in certain cancer cells, delivering chemotherapy directly into the tumor. Trodelvy has shown significant clinical benefit in improving survival outcomes in patients with triple-negative breast cancer (TNBC) and HR-positive/HER2-negative breast cancer, particularly in cases where other treatments have failed. It is considered a breakthrough therapy in oncology due to i
Benefits
- Targeted delivery of chemotherapy directly to cancer cells
- Improves overall survival in advanced breast cancer
- Effective in treatment-resistant cancers
- Reduces tumor progression
- Provides an option when standard chemotherapy fails
Indications and Usage
Trodelvy 180 mg Vial is indicated for:
- Metastatic triple-negative breast cancer (TNBC) after ≥2 prior therapies
- Metastatic HR-positive / HER2-negative breast cancer after multiple prior treatments
- Certain cases of advanced cancers under specific clinical conditions
How it Works
Trodelvy is a Trop-2 directed antibody-drug conjugate:
- The antibody binds to Trop-2 protein on cancer cells
- Delivers chemotherapy (SN-38) directly into the tumor
- Causes DNA damage and cancer cell death
This targeted mechanism improves effectiveness while limiting systemic toxicity.
Dosage & Administration
- Administered as intravenous infusion
- Standard dose: 10 mg/kg
- Given on Day 1 and Day 8 of a 21-day cycle
- Must be administered in a hospital or oncology setting
Side Effects
Common side effects:
- Neutropenia (low white blood cells)
- Diarrhea
- Nausea and vomiting
- Fatigue
- Hair loss
Serious side effects:
- Severe neutropenia (infection risk)
- Severe diarrhea
- Hypersensitivity reactions
- Bone marrow suppression
Immediate medical attention is required for severe symptoms.
Warning and Precaution
- High risk of severe neutropenia and infections
- Monitor blood counts regularly
- Manage diarrhea promptly
- Use caution in liver impairment
- Avoid during pregnancy and breastfeeding
- Requires strict oncologist supervision
Patient Guidance
- Treatment must be supervised by an oncologist
- Attend all scheduled infusion sessions
- Report fever or infection symptoms immediately
- Stay hydrated and follow dietary advice
- Avoid pregnancy during treatment
- Regular blood tests are required
Clinical Trial & Approvals
Trodelvy is a globally approved oncology drug:
- First approved by the FDA in 2020
- Approved for metastatic TNBC and HR+/HER2- breast cancer
- Approved in the EU by the European Medicines Agency (EMA) in 2021
- Phase 3 trials (TROPiCS-02) showed improved survival vs chemotherapy
References
1. FDA approval for metastatic TNBC
➤ https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-sacituzumab-govitecan-triple-negative-breast-cancer
2. FDA approval for HR+/HER2- breast cancer
➤ https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer
3. EMA Trodelvy overview
➤ https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy
4. Clinical trial (TROPiCS-02 study)
➤ https://www.gilead.com/news/news-details/2023/european-commission-approves-gileads-trodelvy-for-pre-treated-hrher2–metastatic-breast-cancer
5. Drug mechanism and classification
➤ https://en.wikipedia.org/wiki/Sacituzumab_govitecan
FAQ
What is Trodelvy 180 mg used for?
A: It is used to treat advanced or metastatic breast cancer after prior treatments.
Is Trodelvy chemotherapy?
A: It is a targeted therapy combined with chemotherapy (ADC).
How is it administered?
Through intravenous infusion in a hospital.
Can it cure cancer?
No, but it helps control disease progression and improve survival.
Who should use this medicine?
Patients with advanced breast cancer who have failed previous therapies.
Is it available internationally?
Yes, it can be sourced globally with proper prescription and documentation.
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