NEW YORK – Guardant Health Japan said Friday that the Ministry of Health, Labour, and Welfare (MHLW) approved Guardant360 CDx as a companion diagnostic for Janssen Pharmaceutical's amivantamab-vmjw.
The liquid biopsy test is used to identify inoperable or recurrent non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations, who would be candidates for amivantamab-vmjw combined with chemotherapy.
The MHLW approved Guardant360 CDx for comprehensive genomic profiling of patients with advanced solid tumors in March 2022. The 74-gene assay is also approved as a companion diagnostic for several cancer drugs available in Japan, including Merck's Keytruda (pembrolizumab) for microsatellite instability-high solid tumors, Bristol Myers Squibb's Opdivo (nivolumab) for advanced colorectal cancers, and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for breast cancer.
Janssen filed for regulatory approval of amivantamab-vmjw in combination with chemotherapy in Japan last year. In March, the medication, branded as Rybrevant in the US, received US Food and Drug Administration approval in combination with chemotherapy as a first-line treatment for patients with advanced NSCLC whose tumors harbor EGFR exon 20 insertion mutations.