On September 5, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported 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) (Press release, Guardant Health, SEP 5, 2023, View Source [SID1234634925]). ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.
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Mutations 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.
"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."
In 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 cancer who may benefit from Opdivo (nivolumab), and patients with metastatic NSCLC who may benefit from treatment with LUMAKRAS (sotorasib).
About Guardant360 CDx
For 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.
Since being introduced, Guardant360 has become widely accepted for blood-based comprehensive genomic profiling with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 400,000 tests performed to date, and is broadly covered by Medicare and private payers, insuring over 300 million people.