FDA Approves Guardant360 CDx for HER2-Mutant NSCLC

On August 12, 2022, the U.S. Food and Drug Administration (FDA) approved Guardant360^® CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC), whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, for treatment with AstraZeneca and Daiichi Sankyo's Enhertu^® (fam-trastuzumab deruxtecan-nxki).

For more information, read Guardant Health's announcement.

Posted 8/15/2022