Is Trodelvy approved by the FDA?
Yes, Trodelvy (sacituzumab govitecan-hziy) is FDA approved. It received accelerated approval on April 22, 2020, for the treatment of relapsed or refractory metastatic triple-negative breast cancer (TNBC) in adults who have received at least two prior therapies for metastatic disease. This approval was based on the overall response rate and duration of response, with continued approval contingent upon verification and description of clinical benefit in confirmatory trials. Trodelvy gained full approval for TNBC on April 7, 2021.
What is Trodelvy?
Trodelvy is a targeted antibody-drug conjugate (ADC) designed to treat certain types of advanced or metastatic cancers. It consists of sacituzumab, an antibody that targets the Trop-2 protein, linked to SN-38, an active metabolite of the chemotherapy drug irinotecan. Trop-2 is overexpressed in many cancer cells, making it a suitable target for this treatment.
Indications for Trodelvy
Trodelvy is used to treat:
- Triple-negative breast cancer (TNBC): For adults with metastatic TNBC who have received at least two prior therapies.
- Hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer: For adults who have received endocrine therapy and at least two additional treatments for metastatic disease.
- Urothelial cancer: For adults who have received a platinum-containing chemotherapy and an immunotherapy medicine.
Mechanism of Action
Trodelvy works by targeting Trop-2-expressing cancer cells, binding to them, and then being internalized by these cells. Once inside, the linker between sacituzumab and SN-38 is hydrolyzed, releasing SN-38 directly into the cell. SN-38 inhibits topoisomerase I, leading to DNA damage, cell death, and reduced tumor growth.
Clinical Benefits
In clinical trials for metastatic HR+/HER2- breast cancer, Trodelvy demonstrated a median overall survival benefit of 3.2 months compared to single-agent chemotherapy (14.4 months vs. 11.2 months). Additionally, Trodelvy reduced the risk of disease progression or death by 34%, with a median progression-free survival of 5.5 months versus 4.0 months for chemotherapy.
Approval Timeline
- April 22, 2020: Accelerated approval for metastatic triple-negative breast cancer (TNBC).
- April 7, 2021: Full approval for metastatic TNBC.
- April 13, 2021: Accelerated approval for metastatic urothelial cancer.
- February 3, 2023: Full approval for metastatic HR+/HER2- breast cancer.
Side Effects and Warnings
Common side effects:
- Decreased white and red blood cell counts
- Fatigue
- Hair loss
- Constipation
- Elevated blood sugar levels
- Decreased appetite
Serious side effects:
- Severe neutropenia and diarrhea (black box warning)
- Hypersensitivity and infusion-related reactions, including anaphylaxis
Precautions
Patients should inform their healthcare provider about any medical conditions, especially those related to liver problems, pregnancy, breastfeeding, and genetic predispositions affecting drug metabolism. Women of childbearing potential should use effective contraception during and after treatment due to potential fetal harm.
Administration
Trodelvy is administered intravenously on Days 1 and 8 of a 21-day treatment cycle. Pre-medications are provided to prevent nausea, vomiting, and infusion reactions.
Conclusion
Trodelvy is a significant advancement in the treatment of certain advanced or metastatic cancers, offering new hope for patients with limited options. Its FDA approvals underscore its potential benefits, although careful monitoring for side effects is essential.
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