FDA Approves Trodelvy (Sacituzumab govitecan-hziy) for Triple Negative Breast Cancer

The US Food and Drug Administration (FDA) approved a new type of therapy for triple-negative breast cancer that has spread to other parts of the body and hasn’t responded to other treatments. Triple-negative breast cancer is called that because the cancer cells don’t have estrogen or progesterone receptors and also don’t make too much of the protein called HER2. It has few treatment options and tends to grow and spread faster than other types of breast cancer.

Trodelvy (sacituzumab govitecan-hziy) is a type of targeted therapy called an antibody drug conjugate. It works by delivering a chemotherapy drug directly to the cancer cell which keeps it from growing and spreading. Evidence shows it can help people with metastatic triple-negative breast cancer, who have already received at least 2 other therapies.

The FDA based its approval of the drug on a clinical trial of 108 people that measured the overall response rate, the number of people whose tumors shrank by a certain amount. The drug was given through an intravenous (IV) infusion once a week for 2 weeks, with a break during the third week before starting again. The overall response rate was 33%, one-third of the patients. The improvement lasted for an average of 7.7 months. Of those who got better with Trodelvy, a little over half (55%) continued to have a response for 6 months or more and about 16% maintained their response for a year or more.

The most common side effects were nausea, vomiting, low red or white blood cells, diarrhea, constipation, fatigue, hair loss, loss of appetite, rash, and abdominal pain.

Trodelvy comes with a boxed warning about the possibility of very low blood cell counts and severe diarrhea. Doctors should check patients for these side effects as well as allergic reactions and infusion-related reactions. If needed, doctors should treat patients for these side effects, lower the dose of the drug, or even consider stopping it.

Women who are pregnant should not take Trodelvy because it may harm a fetus or newborn baby. Women of reproductive age should use birth control while taking Trodelvy and continue for 6 months after the last dose. Men who are getting Trodelvy and who have a female partner of reproductive age should also use birth control while on the medicine and for 3 months after the last dose.

The FDA approved Trodelvy using several approaches designed to make drugs for serious diseases available to patients faster: accelerated approval, breakthrough therapy, priority review, and fast track designation. Another clinical trial will be required to confirm the results.

Trodelvy is marketed by Immunomedics, Inc.