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FDA Approves Merck KGaA's Tepmetko for Non-Small Cell Lung Cancer With METex14 Alterations

NEW YORK -- EMD Serono, a subsidiary of Merck KGaA, said on Wednesday that the US Food and Drug Administration has approved its oral MET inhibitor tepotinib (Tepmetko) for metastatic non-small cell lung cancer patients whose tumors harbor MET exon 14 skipping alterations.

The agency granted accelerated approval for the agent based on the overall response rates seen in a Phase II clinical trial, dubbed VISION, which enrolled both treatment-naïve and previously treated patients. All the patients had confirmed MET exon 14 skipping alterations detected in a tissue biopsy, or in a plasma sample when a tissue biopsy was unavailable.

Among 69 NSCLC patients who had not received prior treatment, the overall response rate was 43 percent, and the median duration of response was 10.8 months. Among the 83 patients who had received prior treatment, these outcomes were 43 percent and 11.1 months, respectively.

MET exon 14 skipping mutations occur in roughly three to four percent of NSCLC tumors and are often associated with a poor prognosis.

Tepotinib's US approval comes after the drug was approved in Japan last May. The Japanese Ministry of Health, Labor, and Welfare also approved ArcherDx's ArcherMET assay, which detects MET exon 14 skipping mutations in both tissue and plasma, as the agent's companion diagnostic. In December, EMD Serono also entered into an agreement with Amoy Diagnostics to develop a companion diagnostic for tepotinib in China.

The FDA, however, has not specified a companion diagnostic for selecting eligible patients for tepotinib.