Site Editor
William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, May 6, 2022
On May 4, the U.S. Food and Drug Administration (FDA) approved the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eligible patients had to have received a prior anti-HER2–based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and had to have developed disease recurrence during or within 6 months of completing therapy. The recommended dose is 5.4 mg/kg once every 3 weeks, given as an intravenous infusion.
Previously, trastuzumab deruxtecan received accelerated approval for adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting, based on the results of the trial. This confirmatory multicenter, open-label, randomized trial included 524 patients with HER2-positive, unresectable and/or metastatic breast cancer who received prior trastuzumab and taxane therapy for metastatic disease or developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. They were randomly assigned 1:1 to receive either trastuzumab deruxtecan or ado-trastuzumab emtansine (T-DM1) by intravenous infusion every 3 weeks until unacceptable toxicity or disease progression.
The median progression-free survival was not reached (95% confidence interval [CI] = 18.5 to not estimable) in the trastuzumab deruxtecan arm and 6.8 months (95% CI = 5.6–8.2 months) in the T-DM1arm. At the time of this analysis, 16% of patients had died, and overall survival data were immature. The confirmed objective response rate was 82.7% (95% CI = 77.4%–87.2%) in the trastuzumab deruxtecan arm and 36.1% (95% CI = 30.0%–42.5%) for those receiving T-DM1.
U.S. Food and Drug Administration
JNCCN Spotlights
