FDA Approves Enhertu, First Targeted Therapy for HER2-Low Breast Cancer
Today, the FDA approved Enhertu for treating patients with unresectable or metastatic HER2-low breast cancer. An IV infusion treatment, it is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The drug received priority review and breakthrough therapy designations for the indication, and approval was granted to Daiichi Sankyo four months ahead of the Prescription Drug User Fee Act (PDUFA) deadline.
“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research in a press release. “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”
The approval is based on the randomized, multicenter DESTINY-Breast04 (open label clinical trial), which enrolled 557 adult patients with unresectable or metastatic HER2-low breast cancer. The trial included two cohorts: 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients. Of these patients, 373 randomly received Enhertu by intravenous infusion every three weeks and 184 randomly received physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine, nab paclitaxel or paclitaxel). The results showed improvement in both progression-free survival and overall survival in people with unresectable or metastatic HER2-low breast cancer.
“HER2 receptors, which are proteins made by the HER2 gene, are important in determining a patient’s treatment. HER2-negative includes hormone receptor positive and triple negative breast cancers. HER2-low is a new classification of the HER2 subtype. It describes a new subtype of breast cancer that has some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive,” FDA stated in the release. “Patients with HER2-low breast cancer are eligible for Enhertu if they have received a prior chemotherapy in the metastatic setting, or their cancer returned during, or within 6 months of completing, adjuvant chemotherapy.”
Source: FDA News Release