Daiichi Sankyo Company, Limited announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S. ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In the single-arm, phase 2 DESTINY-Breast01 trial that included 184 female patients with HER2 positive metastatic breast cancer, ENHERTU (5.4 mg/kg) achieved a confirmed objective response rate of 60.3% (n=111; 95% CI: 52.9-67.4), including a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103).1 The median duration of response was 14.8 months (n=111; 95% CI: 13.8-16.9).