Guardant Health Japan Corp announced its submission of 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 submission aims to use the panel as a companion diagnostic for Janssen Pharmaceutical K.K.’s amivantamab-vmjw, in combination with chemotherapy, for 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 this precision medicine in Japan.
Lung cancer is one of the most common and lethal cancers worldwide, with NSCLC accounting for approximately 80-85% of all lung cancer cases. In Japan, over 136,000 new cases of lung cancer were diagnosed in 2022. If approved, this regulatory application would enhance access to targeted treatment options for patients in Japan with inoperable or recurrent NSCLC harbouring EGFR exon 20 insertion mutations. It would also mark Guardant360 CDx as the first blood-based companion diagnostic approved in Japan for detecting EGFR exon 20 insertion mutations.
The Guardant360® CDx was previously approved by the MHLW in March 2022 for comprehensive genomic profiling in patients with advanced solid tumours. This test examines 74 cancer-related genes and is approved as a companion diagnostic for multiple cancer drugs in Japan.
The approval of the Guardant360® CDx as a companion diagnostic for amivantamab-vmjw would represent a significant advancement in the availability of precision medicine for lung cancer patients in Japan.
EDX Medical Group Plc (AQSE:EDX) is a global specialist in digital clinical diagnostics; developing and supporting high-performance products and services to provide cost-effective prediction of disease risk, inform clinical decision-making, enable personalised healthcare and accelerate the development of new medicines for cancer, neurology, heart disease and infectious diseases. EDX Medical entered into a strategic agreement with Guardant Health Inc., under which they distribute Guardant360® CDx and Guardant Reveal™.
