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How does trodelvy treat breast cancer?

See the DrugPatentWatch profile for trodelvy

How Trodelvy Targets Breast Cancer Cells


Trodelvy (sacituzumab govitecan) treats certain breast cancers by delivering chemotherapy directly to tumor cells. It combines a monoclonal antibody that binds to Trop-2—a protein overexpressed on many breast cancer cells—with SN-38, the active form of irinotecan chemotherapy.[1] Once bound, the antibody pulls the drug inside the cell, where SN-38 damages DNA and triggers cell death. This approach limits exposure to healthy tissues compared to traditional chemo.[2]

Which Breast Cancers Does It Treat?


Trodelvy is FDA-approved for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults who received at least two prior therapies, including a taxane and an anthracycline.[1] It showed efficacy in the ASCENT trial, where it extended median progression-free survival to 5.6 months versus 1.7 months with standard chemo, and overall survival to 12.1 months versus 6.7 months.[3]

How Is Trodelvy Administered?


Patients receive Trodelvy intravenously on days 1 and 8 of a 21-day cycle: 10 mg/kg for the first two cycles, then 10 mg/kg if tolerated.[1] Treatment continues until disease progression or unacceptable toxicity. Premedication with antihistamines, acetaminophen, and steroids reduces infusion reactions.

Common Side Effects and Management


Neutropenia (62%), diarrhea (64%), and nausea (64%) are frequent; severe cases include febrile neutropenia (6%) and infections.[1] Dose reductions occur in about 25% of patients. Monitoring blood counts and hydration helps manage these. Unlike antibody-drug conjugates targeting HER2, Trodelvy's Trop-2 focus suits TNBC lacking those markers.

How Does It Compare to Other TNBC Treatments?


| Treatment | Mechanism | Key Trial PFS (months) | OS Benefit |
|-----------|-----------|-------------------------|------------|
| Trodelvy | Trop-2 + topoisomerase inhibitor | 5.6[3] | Yes (HR 0.48) |
| Capecitabine | Oral chemo | 1.7 (ASCENT control)[3] | No |
| Eribulin | Microtubule inhibitor | ~2.6 (prior studies) | Modest |
| Sacituzumab tirumotecan (experimental) | Similar Trop-2 ADC | Ongoing trials | N/A |

Trodelvy outperforms single-agent chemo in pretreated TNBC but lacks head-to-head data with immunotherapy combos like pembrolizumab plus chemo.[4]

Ongoing Approvals and Research


Beyond TNBC, Trodelvy gained approval for HR+/HER2- metastatic breast cancer post-endocrine and CDK4/6 inhibitor therapy (TROPiCS-02 trial: PFS 5.5 vs. 4.0 months).[5] Trials explore earlier lines, combinations with PARP inhibitors, and other cancers like urothelial.

Sources
[1]: Trodelvy Prescribing Information (FDA)
[2]: Gilead Sciences Mechanism Overview
[3]: ASCENT Trial (NEJM 2021)
[4]: KEYNOTE-355 Trial Summary
[5]: TROPiCS-02 Results (NEJM 2023)



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