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Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for Daiichi Sankyo and AstraZeneca’s ENHERTU® for Treatment of NSCLC Patients With Activating HER2 Mutations
Blood test provides simple way to test patients comprehensively for tumor alterations that drive selection of targeted therapies, now including ENHERTU PALO
About this update from Guardant Health, Inc.
[{"type":"text","content":"\nBlood test provides simple way to test patients comprehensively for tumor alterations that drive selection of targeted therapies, now including ENHERTU\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approved its 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 HER2 (ERBB2) mutations for treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.\n\nThe approval means that Guardant360 CDx, a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood, is validated as a CDx assay to identify NSCLC patients who have an activating HER2 mutation (SNVs and exon 20 insertions) and may benefit from treatment with ENHERTU. Mutations in the HER2 gene, also called ERBB2, drive approximately 2-4% of non-squamous NSCLC.1 Non-small cell lung cancer represents about 82% of all lung cancer,2 which is the leading cause of cancer death in the U.S.3\n\n“This is great news for metastatic NSCLC patients with activating HER2 mutations, who now have, for the first time, an approved treatment for their cancer, but also the first blood-based companion diagnostic in Guardant360 CDx,” said Helmy Eltoukhy, Guardant Health co-CEO. “We are proud to offer our Guardant360 CDx liquid biopsy as a companion diagnostic so that patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy.”\n\nGuardant360 CDx\n\nFor oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.\n\nSince being introduced as a laboratory developed test (LDT), the Guardant360 test has bec...