Trodelvy® (sacituzumab govitecan-hziy)
How is it designed to work?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
TRODELVY® (sacituzumab govitecan-hziy)
How is it designed to work?
This information is provided in response to your question. It is not treatment advice on how to use TRODELVY. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the TRODELVY Patient Information for more details, including approved use(s) and important warnings: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_patient_pi.pdf
The short answer
| TRODELVY is a type of medicine known as an antibody drug conjugate (ADC) that can treat certain types of breast cancer. ADCs work by attaching to proteins or receptors found on certain cells including cancer cells, allowing them to deliver medicine directly to the cell.1 |
| Some cancer cells have a higher amount of proteins called Trop-2 than normal or non-cancer cells.2 TRODELVY attaches to cells with Trop-2 and delivers a chemotherapy medicine directly to kill cells or stop them from growing.1 |
Who is TRODELVY for?1
TRODELVY is a prescription medicine used in adults to treat:
- a type of cancer called triple-negative breast cancer (TNBC) which is estrogen and progesterone hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative that has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic)
As the first treatment:
- alone when your TNBC cannot be removed by surgery and you are not a candidate for PD-1 or PD-L1 inhibitor-based therapy
- with the medicine pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph when your TNBC cannot be removed by surgery and the tumors test positive for PD-L1
As the second or later treatment:
- after you have received 2 or more prior therapies throughout the body (systemic) for TNBC that cannot be removed by surgery and at least 1 of the therapies was for metastatic TNBC.
- a type of cancer called hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer that has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic)
- when your HR-positive, HER2-negative breast cancer cannot be removed by surgery and you have received hormonal-based therapy and at least 2 more therapies throughout the body (systemic) for metastatic breast cancer
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children. |
What is TRODELVY made of?1
| TRODELVY is a type of medicine known as an ADC. ADCs are made up of three parts:
|
How is it designed to work?
Information from laboratory studies suggests that this is how TRODELVY works. The clinical benefit of these observations is unknown. Some cancer cells have a higher amount of a protein on their surface called Trop-2 than normal or non-cancer cells.2 When a person is treated with TRODELVY, the antibody part of TRODELVY finds and attaches to Trop-2.1 | |
| |
Glossary
- Antibodies: proteins in our immune system that are normally used to fight infections but can also be made for use as treatments for certain conditions
- Antibody drug conjugate (ADC): a type of cancer medicine that delivers chemotherapy directly to cancer cells using a linked antibody
- Chemotherapy: a medicine that can kill cancer cells or stop them from growing
- Hormonal-based therapy: a type of medicine that works by blocking or changing hormones in your body. It is often used to treat certain cancers, like some breast cancers, that rely on hormones to grow
- Hormone receptor (HR): a hormone is a substance made by a gland in your body. A receptor is a protein found inside or on the surface of a cell. When hormones attach (bind) to specific receptors, it causes changes within the cell. There are 2 types of hormone receptors, estrogen and progesterone
- Human epidermal growth factor receptor (HER2): HER2 is a protein that can affect cell growth. A receptor is a protein found inside or on the surface of a cell. When proteins attach (bind) to specific receptors, it causes changes within the cell
- Locally advanced: cancer that has spread to nearby tissues
- Linker: keeps the chemotherapy medicine attached to the antibody on an antibody drug conjugate until the cancer cell is reached
- Metastatic: spread of cancer from the place where it started to other parts of the body
- PD-L1: a protein that is present on some people’s tumors, and that can be targeted by specific medications called anti-PD-1 or anti-PD-L1 treatments.
- Sacituzumab: the antibody part of TRODELVY
- SN-38: the chemotherapy drug part of TRODELVY
- Triple-negative breast cancer (TNBC): a type of breast cancer that does not use hormones or HER2 protein to grow
- Trophoblast cell-surface antigen 2 (Trop-2): is a protein found on the surface of many types of cells. In some cancers, such as breast cancer, Trop-2 is found in much higher amounts than normal cells
References
- TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.
- Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018;9(48):28989-29006.
More information about TRODELVY
If you would like more detailed information about TRODELVY, please visit:
https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for TRODELVY. It will tell you about the uses, warnings, and other important safety information about TRODELVY.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for TRODELVY. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of TRODELVY in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your healthcare provider.
Follow-Up
For any additional questions, please contact Trodelvy Medical Information at:
☎1‐888-983-4668 or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
Data Privacy
The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.
It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact gilead.privacy@gilead.com.
TRODELVY GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2026 Gilead Sciences, Inc.
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Report side effects
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FDA MedWatch
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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch.