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Trastuzumab deruxtecan FDA approval in metastatic NSCLC

Oncologyme  /  Mar 26, 2023

On August 11, 2022, the FDA approved #fam-trastuzumab deruxtecan-nxki (5.4 mg/kg IV every 3 weeks) for adult patients with have unresectable or metastatic HER2-mutant non-squamous #NSCLC with disease progression after prior systemic therapy. The accelerated approval was based on phase 2 DESTINY-Lung02 trial that demonstrated clinically meaningful activity of T-DXd with ORR of 53.8%.