Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. For more information about this approval, you can find Daiichi Sankyo’s press release here and AstraZeneca’s press release here.
See the FDA approved indication and Important Safety Information below. Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.