MONDAY, Aug. 8, 2022 (HealthDay News) — The U.S. Food and Drug Administration has approved Enhertu (am-trastuzumab-deruxtecan-nxki), an intravenous infusion treatment for patients with receptor 2 of unresectable or metastatic human epidermal growth factor (HER2). )-low breast cancer.
HER2-low is a new subclassification within HER2-negative, which describes breast cancer that has some HER2 protein on the cell surface, but not enough to be classified as HER2-positive. Patients with low HER2 are eligible for Enhertu if they have received prior chemotherapy for metastatic disease or if the cancer has returned during adjuvant chemotherapy or within six months of completing chemotherapy.
The approval is based on the results of the DESTINY-Breast04 randomized trial, in which 373 patients received Enhertu every three weeks and 184 received physician’s choice chemotherapy. Both progression-free survival and overall survival improved in patients with HER2-low unresectable or metastatic breast cancer receiving Enhertu. Nausea, fatigue, alopecia, vomiting, constipation, decreased appetite, musculoskeletal pain and diarrhea were the most common adverse reactions.
“Today’s approval underscores the FDA’s commitment to being at the forefront of scientific advances, making cancer treatment options available to more patients,” said Richard Pazdur, MD, director from the FDA’s Oncology Center of Excellence, in a statement. “Having therapies that are specifically tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”
Enhertu’s approval was granted to Daiichi Sankyo.
