What is Trodelvy™ (sacituzumab govitecan-hziy)?
Trodelvy™ (sacituzumab govitecan-hziy) is an intravenous (IV) infusion medication that may be used to treat adult patients with triple-negative breast cancer (TNBC) that is metastatic (has spread to other parts of the body) and who were previously treated with two or more other therapies for metastatic breast cancer.1,2 Trodelvy is the first antibody-drug conjugate (anti-Trop-2 ADC) approved by the US Food & Drug Administration (FDA) specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer. Trodelvy is manufactured by Immunomedics, Inc.1,2
What is the active ingredient in Trodelvy?
The active ingredient in Trodelvy is sacituzumab govitecan-hziy.1,2
How does Trodelvy work?
About 20 percent of breast cancer cases worldwide are triple-negative.1 This means it tests negative for estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2) protein. This type of cancer does not respond to hormone therapy or treatments that target HER2.1
Trodelvy is comprised of two parts, a monoclonal antibody and a chemotherapy medication. By combining the antibody and chemotherapy medication together, the antibody portion helps to find and attach to the Trop-2 containing breast cancer cells, and once attached, the chemotherapy portion is released to attack the cancer cell.
Chemotherapy has been the standard treatment for triple-negative breast cancer. Trodelvy is a targeted therapy for people with metastatic triple-negative breast cancer. It offers another treatment option for people who continue to have active disease.1
What are some of the possible side effects of Trodelvy?
The most common side effects of Trodelvy include1,2:
- Nausea and vomiting
- Low white blood cell counts
- Hair loss
- Decreased appetite or stomach pain
- Low red blood cell counts
Trodelvy can cause less common, but serious side effects including2:
- Severe decrease in white blood cells (neutropenia)
- Severe diarrhea
- Serious infusion reactions and anaphylaxis
Before starting the Trodelvy infusion, you may receive premedication to prevent treatment-related nausea and vomiting. Your healthcare team will monitor you during treatment and for at least 30 minutes after the end of infusion.2
In some cases, a therapy called granulocyte-colony stimulating factor (G-CSF) can be given to stimulate the bone marrow to produce certain forms of white blood cells.
This can help prevent infection. Anti-infective treatment may be necessary in people who develop a fever along with neutropenia.2
If severe diarrhea develops you will be given fluid, electrolytes, and other medications, as needed.
Some people who have severe side effects may need to stop treatment or get a lower dose of Trodelvy to manage adverse reactions.1,2
Trodelvy may cause harm to a developing fetus or newborn baby. Pregnant women should not take Trodelvy. While receiving Trodelvy, men with female partners who can become pregnant, and women who can become pregnant, should both use effective contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor).1,2
These are not all the possible side effects of Trodelvy. Talk to your doctor for more information or if you notice any new or worsening side effects including fever, chills, or other signs of infection.2
Things to know about Trodelvy
Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options.1 The FDA granted accelerated approval to Trodelvy because preliminary clinical results showed it may fill an unmet medical need.1-2 It received Priority Review and Breakthrough Therapy designation. The continued approval for this treatment may depend on the outcome of future trials.
Talk to your doctor about all drugs (prescription and over the counter), supplements, and vitamins you are taking. Some drugs or supplements may interfere with each other. This could mean certain medications may have decreased effectiveness, or you may have serious side effects. While taking Trodelvy your doctor may adjust the doses of some of the other drugs you take. Before starting treatment with Trodelvy, patients should tell their doctor about all their health conditions, including if you1,2:
- Have any known medication allergies
- Have a gene known as uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28
- Have low white blood cell counts
Patients should talk to their doctor if they have any questions, or if they have questions regarding their Trodelvy regimen.
For more information, read the full prescribing information of Trodelvy.