In May 2022, the FDA granted a regular full approval for Enhertu (fam-trastuzumab deruxtecan-nxki; from Daiichi Sankyo) for adults with unresectable or metastatic HER2-positive breast cancer who had previously received an anti-HER2 regimen in the metastatic or the neoadjuvant or adjuvant setting whose disease returned during or within 6 months of completing therapy, based on the confirmatory DESTINY-Breast03 clinical trial.
“Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2-positive metastatic breast cancer. Today’s approval is an important milestone for the clinical community, as we will now be able to offer Enhertu to these patients earlier in their treatment,” said Erika Hamilton, MD, Director of the Breast Cancer and Gynecological Cancer Research Program, Sarah Cannon Research Institute, Nashville, Tennessee.
This regular approval was based on a confirmatory clinical trial that was conducted after the FDA accelerated the approval of Enhertu in December 2019 for adults with unresectable or metastatic HER2-positive breast cancer who had received 2 or more anti-HER2 regimens for metastatic breast cancer.
