FDA approved a new treatment for triple-negative breast cancer patients

We are witnessing a new hope for patients with triple-negative breast cancer. The FDA recently approved a new antibody-drug conjugated targeted therapy called Trodelvy (sacituzumab govitecan-hziy). Trodelvy works directly on cancer cells which keeps them from growing and spreading. The approval is limited for patients that already received at least 2 other therapies. Triple-negative breast cancer is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein.

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. Trodelvy is 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.

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. Trodelvy is marketed by Immunomedics, Inc.