What Is It, and Why Does It Matter?
Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate that targets a protein called Trop-2 on many breast cancer cells. It brings a chemotherapy payload, SN-38, straight to those cells. Once inside, SN-38 is released, damages the cell’s DNA, and can lead to cell death.
The FDA has approved Trodelvy for adults with triple-negative breast cancer (TNBC) that has spread or cannot be removed with surgery, for use as a first treatment. You can receive it alone if you are not a candidate for medicines that block PD-1 or PD-L1, or with Pembrolizumab if your tumor tests positive for programmed death ligand 1 (PD-L1) using an FDA-authorized test.
Trodelvy also has other approved uses. You can receive it for TNBC after at least two earlier treatments. It is also approved for hormone receptor (HR)-positive, HER2-negative metastatic breast cancer when the cancer has grown after hormonal therapy and at least two other systemic treatments.
TNBC is an aggressive form of breast cancer and makes up about 15% of all cases. Few new first treatments have been available in recent years, and many people never get beyond first treatment because of illness or side effects. These new approvals let you start Trodelvy either alone (if PD-1 or PD-L1 treatment is not an option) or with Pembrolizumab (if your tumor is PD-L1–positive), adding a targeted option at the start of care.
Why Was It Approved?
The FDA based its decision on two randomized studies in people who had not received prior treatment for advanced TNBC. In one study, for those who could not receive PD-1 or PD-L1 inhibitor therapy, Trodelvy alone kept cancer from getting worse longer than standard single-agent chemotherapy chosen by the health care provider.
In a second study for PD-L1-positive disease, Trodelvy plus Pembrolizumab delayed cancer growth longer than Pembrolizumab plus chemotherapy. Taken together, these studies showed meaningful delays in cancer progression in both first-line settings.
Trodelvy has also shown benefit after earlier treatments. In studies of previously treated TNBC, it improved time without cancer growth and length of life, compared with single-agent chemotherapy. In heavily pretreated HR-positive, HER2-negative metastatic breast cancer, Trodelvy also beat chemotherapy on both measures. These findings add to the overall evidence supporting Trodelvy across breast cancer types, even though they did not drive the new first-line approvals.
Safety was a key part of the review. Trodelvy carries a boxed warning about severe neutropenia (very low white blood cells) and severe diarrhea. Other warnings include allergic and infusion reactions, nausea and vomiting, risks in people with lower activity in their UGT1A1 enzyme (which clears waste and toxins from the body), and harm to a fetus. Common side effects when used alone include low white blood cells and neutrophils, nausea, diarrhea, tiredness, and hair loss. When used with Pembrolizumab, common effects also include rashes, stomach pain, headaches, and certain lab changes.
What Do I Need to Know?
The usual Trodelvy dose is 10 mg/kg by intravenous (IV) infusion on the first and eighth days of a 21-day cycle. You continue until the cancer grows or side effects become too serious. Your health care provider may give premedicines to help prevent infusion reactions, nausea, and vomiting.
Trodelvy can cause very low white blood cells (neutropenia) and severe diarrhea, which can be life-threatening. Your health care provider will check your blood counts often. Call right away if you have a fever, chills, loose stool, or diarrhea that does not stop. People with reduced UGT1A1 activity have a higher risk of neutropenia and may face other side effects more often.
Avoid taking Trodelvy with medicines that block or boost UGT1A1. These can raise the chance of serious side effects or make Trodelvy work less well by changing SN-38 levels.
Trodelvy may harm a fetus. Use birth control during treatment and after the last dose (women: six months; men with partners who can become pregnant: three months). Do not breastfeed during treatment and for a month after your final dose.
Do not take Trodelvy if you had a severe allergic reaction to it in the past. Before starting, review all your medicines, vitamins, and supplements with your health care provider, and share your health history.