FDA Approves Enhertu to Treat HER2-Positive Breast Cancer

The Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-positive breast cancer who have progressed on available therapies.

The drug, which was granted accelerated approval, can be used for those whose tumors can’t be surgically removed or whose cancer has spread to other parts of the body.

The approval is based on results from a clinical trial that included 184 women with HER2-positive, unresectable and/or metastatic breast cancer and showed that 60.3% of patients who received Enhertu had a certain amount of their tumor shrink. The median duration of response was 14.8 months.

The most common side effects of Enhertu are nausea, fatigue, vomiting, hair loss, constipation, decreased appetite, anemia, decreased neutrophil count, diarrhea, leukopenia (other white blood cells that help the immune system), cough and decreased platelet count.

In addition, there is risk of interstitial lung disease, which is a group of lung conditions that causes scarring of lung tissues. Therefore, the medication includes a boxed warning for health care professionals and patients. If a patient experiences cough, labored breathing, fever or other new respiratory symptoms, they should contact their doctor.

Check back for the latest on the FDA’s approval of Enhertu and how it will affect patients.