Guardant Health Japan submits application for regulatory approval of Guardant360® CDx in Japan as companion diagnostic for Janssen lung cancer therapy

July 17, 2024

TOKYO – Guardant Health Japan Corp. (HQ: Minato-ku,Tokyo/ AMEA CEO Simranjit Singh, Japan Representative Director Mika Takaki) announced it submitted a regulatory application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for approval of the Guardant360® CDx comprehensive genomic profiling panel as a companion diagnostic for Janssen Pharmaceutical K.K.’s amivantamab-vmjw combined with chemotherapy in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Janssen Pharmaceutical 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

Approval of the regulatory application would give 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. It would also make Guardant360 CDx the first blood-based companion diagnostic to be approved in Japan for the detection of EGFR exon 20 insertion mutations. Guardant360 CDx was approved by MHLW in March 2022 for comprehensive genomic profiling in patients with advanced solid tumors. The test examines 74 cancer-related genes and is approved as a companion diagnostic for multiple cancer drugs approved in Japan.

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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-toincidence 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 [18 June 2024].