Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research Program; Principal Investigator at Sarah Cannon Research Institute. In this video, she speaks about the Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.
Enhertu (trastuzumab deruxtecan) has been approved in the United States for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2-based regimen, either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have experienced disease recurrence during or within six months of completing therapy.
AstraZeneca and Daiichi Sankyo are developing and commercializing Enhertu, a precisely tailored HER2-directed antibody drug combination (ADC).
The FDA approved Enhertu based on positive results from the DESTINY-Breast03 Phase III trial, which found that Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95 percent confidence interval [CI]: 0.22-0.37; p0.0001) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with tras
The approval was granted under the FDA's Real-Time Oncology Review (RTOR) program and converts Enhertu's earlier line HER2-positive metastatic breast cancer approval to standard approval, broadening Enhertu's breast cancer indication in the US to earlier lines of use in patients with HER2-positive metastatic breast cancer.