medwireNews: The antibody–drug conjugate fam-trastuzumab deruxtecan-nxki has received regular approval from the US FDA for the treatment of HER2-positive advanced breast cancer.
The agent is indicated for individuals with unresectable or metastatic disease who have received prior HER2-targeted therapy in the metastatic setting or in the perioperative setting but with disease relapse during or within 6 months of completing treatment.
Trastuzumab deruxtecan previously received accelerated approval in December 2019 for patients who had received at least two lines of anti-HER2-based therapy for unresectable or metastatic HER2-positive breast cancer.
The regular approval follows the results of the phase 3 DESTINY-Breast03 trial showing a significant 72% reduction in the risk for progression or death with trastuzumab deruxtecan versus trastuzumab emtansine in previously treated patients.
The FDA recommends that trastuzumab deruxtecan should be given at a dose of 5.4 mg/kg every 3 weeks.
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