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Guardant Health Japan Seeks Regulatory Approval for Guardant360® CDx as Companion Diagnostic for Janssen's Lung Cancer Therapy in Japan

NextEdge Admin

17 Jul 2024

2 min 34 sec

Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ AMEA CEO Simranjit Singh, Japan Representative Director Mika Takaki) has submitted a regulatory application to Japan's Ministry of Health, Labour and Welfare (MHLW) for the approval of the Guardant360® CDx comprehensive genomic profiling panel. This application seeks to use Guardant360® CDx 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) harboring EGFR exon 20 insertion mutations. Janssen Pharmaceutical is also pursuing regulatory approval in Japan for amivantamab-vmjw, a precision medicine for this patient population.

Lung cancer remains one of the most prevalent and lethal cancers worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 80-85% of all lung cancer cases. In Japan, over 136,000 new lung cancer cases were diagnosed in 2022 alone. Approval of this application would provide patients with inoperable or recurrent NSCLC that has EGFR exon 20 insertion mutations access to targeted treatment options like amivantamab-vmjw combined with chemotherapy. Furthermore, it would mark the Guardant360 CDx as the first blood-based companion diagnostic approved in Japan for detecting EGFR exon 20 insertion mutations.

Guardant360® CDx, which received MHLW approval in March 2022, is designed for comprehensive genomic profiling in patients with advanced solid tumors. The test analyzes 74 cancer-related genes and is already approved as a companion diagnostic for multiple cancer drugs in Japan. If this application is approved, it would enhance treatment opportunities and precision medicine approaches for NSCLC patients in Japan, potentially improving outcomes and survival rates for this challenging cancer type.