All You Need to Know About Trodelvy and Its Therapeutic Advancements

In the landscape of oncology, advancements in targeted therapies continue to reshape the way we approach and treat various types of cancer. One such groundbreaking therapeutic drug is Trodelvy (sacituzumab govitecan-hziy), a novel antibody-drug conjugate approved for the treatment of metastatic triple-negative breast cancer (mTNBC), hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and metastatic urothelial cancer (mUC).

Approved by the FDA, Trodelvy offers hope to patients facing limited treatment options, demonstrating promising efficacy and tolerability in clinical trials.

Understanding Trodelvy:

Trodelvy is a first-in-class antibody-drug conjugate (ADC) designed to selectively target and deliver chemotherapy to cancer cells expressing the Trop-2 receptor. Trop-2 is overexpressed in a variety of solid tumors, including triple-negative breast cancer, HR-positive/HER2-negative breast cancer, and urothelial cancer, making it an attractive target for therapy. The medicinal product is supplied for injection: 180 mg lyophilized powder in single-dose vials for reconstitution for intravenous use.

Indications for Use:

Trodelvy 180 mgs indicated for the treatment of:

• Metastatic Triple-Negative Breast Cancer (mTNBC): This therapeutic drug is approved for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies for metastatic disease.
• HR-positive/HER2-negative Metastatic Breast Cancer: The medicine is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) in patients who have received two or more prior systemic therapies.
• Metastatic Urothelial Cancer (mUC): Trodelvy is also approved for patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Dosage and Administration:

Trodelvy is administered intravenously under the supervision of a healthcare professional (HCP). The recommended dosage and treatment regimen may vary depending on the type of cancer being treated and the patient's individual characteristics.

Trodelvy is typically administered at a recommended dosage of 10 mg/kg via intravenous infusion once weekly, specifically on Days 1 and 8 within a 21-day treatment cycle. Treatment should be continued until disease progression or if any adverse reactions become unacceptable. It's essential not to exceed the recommended dosage of 10 mg/kg. Close monitoring for potential adverse reactions is essential during treatment with Trodelvy.

How Trodelvy Works:

Trodelvy utilizes a two-part mechanism of action to target and destroy cancer cells:

Targeted Delivery: The monoclonal antibody component of Trodelvy binds specifically to the Trop-2 receptor, which is overexpressed on the surface of cancer cells. This targeting mechanism allows Trodelvy to selectively deliver the attached chemotherapy payload to cancer cells while sparing healthy tissues.

Chemotherapy Payload: Once bound to the Trop-2 receptor, Trodelvy is internalized by the cancer cell, releasing its payload of the chemotherapy drug, SN-38. SN-38 is a potent inhibitor of topoisomerase I, an enzyme essential for DNA replication and cell division. By inhibiting topoisomerase I, SN-38 induces DNA damage and ultimately leads to cancer cell death.

Clinical Efficacy:

Clinical trials evaluating Trodelvy have demonstrated promising results in patients with metastatic triple-negative breast cancer and metastatic urothelial cancer. In a pivotal Phase 3 trial in mTNBC, Trodelvy significantly prolonged progression-free survival and overall survival compared to standard chemotherapy. Similarly, in a Phase 2 trial in mUC, Trodelvy showed durable responses and favorable survival outcomes in patients who had previously received platinum-based chemotherapy and immunotherapy.

Side Effects:

While Trodelvy offers significant therapeutic benefits, it can also cause side effects. Common side effects associated with Trodelvy may include:

• Neutropenia: Treatment with this medication can cause a decrease in white blood cell counts, specifically neutrophils, which can increase the risk of infection.
• Diarrhea: Gastrointestinal symptoms such as diarrhea may occur and should be managed promptly to prevent dehydration.
• Nausea and Vomiting: Some patients may experience nausea and vomiting during treatment with Trodelvy.
• Fatigue: Fatigue or weakness may occur as a result of treatment.

It is essential for patients to communicate any side effects or symptoms to their healthcare provider promptly.

Precautions and Considerations:

While Trodelvy offers significant therapeutic benefits, it is essential to consider precautions and potential risks associated with its use. Patients receiving Trodelvy should be monitored closely for adverse reactions, including:

• Hepatotoxicity: Trodelvy can cause liver damage, as indicated by elevated liver enzymes. Liver function tests should be performed regularly, and patients with pre-existing liver conditions should be closely monitored.
• Interstitial Lung Disease (ILD): ILD, including pneumonitis, can occur with Trodelvy treatment. Patients should report any new or worsening respiratory symptoms, such as cough or difficulty breathing, to their healthcare provider promptly.
• Pregnancy and Breastfeeding: Trodelvy can harm an unborn baby and should not be used during pregnancy. Women of childbearing age should use effective contraception during treatment and avoid breastfeeding.

It is crucial for healthcare providers to assess patients' medical history and closely monitor for potential complications during Trodelvy treatment. Patients should be educated about the importance of reporting any adverse reactions or symptoms to their healthcare provider promptly. By carefully considering precautions and taking appropriate measures, patients and healthcare providers can maximize the benefits of Trodelvy while minimizing risks.

Cost of Trodelvy:

At present, Trodelvy (sacituzumab govitecan) is not currently available in India. However, it's important to note that prices can fluctuate based on variables such as dosage and treatment duration. For the most accurate and current information regarding the cost of Trodelvy in India, Patients, Doctors, and Hospitals are encouraged to reach out to Indian Pharma Network (IPN) via Call/WhatsApp: +91 9310090915.

Conclusion:

Trodelvy represents a significant advancement in the treatment of breast cancer and urothelial cancer, offering a targeted and effective therapy for patients who have progressed on standard treatments. By understanding the indications, mechanism of action, clinical efficacy, and potential side effects associated with Trodelvy, patients and healthcare providers can make informed decisions about treatment options and optimize patient outcomes. Continued research and clinical trials will further elucidate the role of Trodelvy in the evolving landscape of cancer therapy.

Sources  - https://trodelvy.tumblr.com/post/749458531187556352/all-you-need-to-know-about-trodelvy-and-its