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Guardant Health Japan Gains Regulatory Approval for Guardant360® CDx Liquid Biopsy as Companion Diagnostic for Identifying EGFR Exon 20 Insertion Mutations in Inoperable or Recurrent NSCLC

NextEdge Admin

30 Aug 2024

2 min 15 sec

liquid biopsy,comprehensive genomic profiling,diagnostic

Guardant Health Japan Corp., based in Minato-ku, Tokyo, has announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Guardant360® CDx as a companion diagnostic for identifying EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC). This approval marks the first time a blood-based companion diagnostic has been approved in Japan for detecting EGFR exon 20 insertion mutations. The test is used to determine patient eligibility for treatment with amivantamab-vmjw in combination with chemotherapy. Janssen Pharmaceutical K.K., a Johnson & Johnson company headquartered in Chiyoda-ku, Tokyo, is currently seeking regulatory approval for amivantamab-vmjw in Japan.

Lung cancer, particularly NSCLC, is a leading cause of cancer-related deaths globally, accounting for 80-85% of lung cancer cases. In Japan, over 136,000 new cases of lung cancer were diagnosed in 2022. The Guardant360 test identified EGFR exon 20 insertion mutations in 2.4% of East Asian NSCLC patients, including those from Japan, in a retrospective analysis. This regulatory approval provides Japanese patients with inoperable or recurrent NSCLC and EGFR exon 20 insertion mutations greater access to targeted therapies like amivantamab-vmjw combined with chemotherapy.

Guardant360 CDx, which was approved by the MHLW in March 2022 for comprehensive genomic profiling in advanced solid tumors, analyzes 74 cancer-related genes and serves as a companion diagnostic for multiple cancer drugs approved in Japan.