NEW YORK – The Japanese Ministry of Health, Labor, and Welfare has approved the MET Inhibitor tepotinib (Merck KGaA's Tepmetko) for non-small cell lung cancer patients with MET exon 14 skipping alterations, after the drug demonstrated meaningful benefit in objective response across different lines of treatment.
Simultaneously, the agency approved ArcherDX's ArcherMET test as a companion diagnostic to identify patients eligible for treatment. The assay is designed to detect METex14 skipping alterations in both tissue and liquid biopsy samples.