Guardant Health Japan receives regulatory approval of Guardant360® CDx liquid biopsy as companion diagnostic for amivantamab-vmjw to identify patients with inoperable or recurrent NSCLC harbouring EGFR exon 20 insertion mutations

August 30, 2024

TOKYO — Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Guardant360® CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy. This approval makes the Guardant360 CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for the detection of EGFR exon 20 insertion mutations. Janssen Pharmaceutical K.K. (HQ: Chiyoda-ku, Tokyo/ Representative Director: Shuhei Sekiguchi), a Johnson & Johnson company, is currently seeking regulatory approval for the use of amivantamab-vmjw, a precision medicine, in Japan.  

Lung cancer is one of the most prevalent and deadly cancers globally, with non-small cell lung cancer (NSCLC) representing approximately 80-85% of all lung cancer cases.1,2 In Japan, more than 136,000 cases of lung cancer were newly diagnosed in 2022.3 In a retrospective analysis, the Guardant360 test identified EGFR exon 20 insertion mutations in 2.4% of East Asian patients with NSCLC, including those from Japan.4 This regulatory approval of the test gives patients in Japan with inoperable or recurrent NSCLC harbouring EGFR exon 20 insertion mutations a greater opportunity to access targeted treatment options, such as amivantamab-vmjw combined with chemotherapy.

Guardant360 CDx was approved by MHLW in March 2022 for comprehensive genomic profiling in patients with advanced solid tumours. The test examines 74 cancer-related genes and is approved as a companion diagnostic for multiple cancer drugs approved in Japan.

Product information

BiomarkerCancerCompanion diagnostic
KRAS G12CNon-small cell lungsotorasib
ERBB2 (HER2) mutationstrastuzumab deruxtecan 
EGFR exon 20 insertion mutationamivantamab-vmjw
BRAF V600EColorectalencorafenib, binimetinib and cetuximabencorafenib and cetuximab
KRAS/NRAS
wild-type		cetuximab or panitumumab
ERBB2 copy number alteration (HER2 amplification)trastuzumab and pertuzumab
MSI-Highnivolumab
Solidpembrolizumab
Note: Underlined items have been added with this approval
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  1. Bray, F., Laversanne, M., Sung, H., Ferlay, J., Siegel, R. L., Soerjomataram, I., & Jemal, A. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians, 74(3), 229–263. https://doi.org/10.3322/caac.21834
  2. Sharma R. (2022). Mapping of global, regional and national incidence, mortality and mortality-to-incidence ratio of lung cancer in 2020 and 2050. International journal of clinical oncology, 27(4), 665–675. https://doi.org/10.1007/s10147-021-02108-2
  3. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today, accessed [29 July 2024].
  4. Cho, B. C., Loong, H. H. F., Tsai, C. M., Teo, M. L. P., Kim, H. R., Lim, S. M., Jain, S., Olsen, S., & Park, K. (2022). Genomic Landscape of Non-Small Cell Lung Cancer (NSCLC) in East Asia Using Circulating Tumor DNA (ctDNA) in Clinical Practice. Current oncology (Toronto, Ont.), 29(3), 2154–2164. https://doi.org/10.3390/curroncol29030174