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Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations
Blood test provides simple way for oncologists to test patients with advanced NSCLC for genomic alterations that drive selection of HER2-targeted therapy
About this update from Guardant Health, Inc.
[{"type":"text","content":"\nBlood test provides simple way for oncologists to test patients with advanced NSCLC for genomic alterations that drive selection of HER2-targeted therapy\n\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic to select patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy for treatment with ENHERTU® (trastuzumab deruxtecan). ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.\n\n\nMutations in the HER2 gene are responsible for approximately 2-4% of non-squamous NSCLC, which represents about 70% of NSCLC cases.1,2 Overall, NSCLC accounts for about 80-85% of all lung cancer,3 the leading cause of cancer death for men and women worldwide.4 Guardant360 CDx is a next-generation sequencing-based assay that detects genomic alterations using circulating tumor DNA from blood. The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022.\n\n\n“The ministry’s approval of Guardant360 CDx as a companion diagnostic for ENHERTU is great news for patients with metastatic non-small cell lung cancer with HER2 mutations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Oncologists in Japan now have the first blood-based companion diagnostic to determine if their patients are eligible to receive the first HER2 directed therapy approved to treat this specific condition. This is another step forward in achieving Guardant Health’s mission to conquer cancer globally.”\n\n\nIn March 2022, the MHLW approved the Guardant360 CDx test for comprehensive genomic profiling in patients with advanced solid tumors, and in July 2023, the test received national reimbursement approval in Japan. The MHLW also previously approved the test as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab), patients with MSI-High advanced colorectal can...