Trodelvy 180 mg Vial

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