Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, 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.