TRODELVY
Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with specific forms of advanced breast cancer. It is used for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in patients who have received two or more prior systemic therapies. The drug is also approved for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
How TRODELVY Works
Trodelvy functions as an antibody-drug conjugate that targets Trop-2-expressing cancer cells using a humanized antibody. Upon binding to the cell surface, the drug is internalized and releases SN-38, a topoisomerase I inhibitor, via hydrolysis of its linker. SN-38 then interacts with topoisomerase I to prevent the re-ligation of single-strand DNA breaks. This process results in DNA damage that leads to apoptosis and cell death.
Details
- Status
- Prescription
- First Approved
- 2020-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRODELVY Approval History
What TRODELVY Treats
2 indicationsTRODELVY is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
- Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer
TRODELVY Boxed Warning
NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia [see Dosage and Administration (2.3) ] . Initiate anti-infective treatment in patient with febrile neutropenia without delay [see Warnings and Precautions (5.1) ...
WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia [see Dosage and Administration (2.3) ] . Initiate anti-infective treatment in patient with febrile neutropenia without delay [see Warnings and Precautions (5.1) ]. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide [see Warnings and Precautions (5.2) ]. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses [see Dosage and Administration (2.3) ]. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning . TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. ( 2.3 , 5.1 ) TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. ( 2.3 , 5.2 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRODELVY FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Locally Advanced or Metastatic Breast Cancer Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additi...
WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all pa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.