European Commission Approves TEPMETKO? (tepotinib) for Patients with Advanced NSCLC with METex14 Skipping Alterations

發(fā)布時(shí)間： 2022-02-28 閱讀：465次

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February 18, 2022 —Merck, a leading science and technology company, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO? (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

TEPMETKO is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping.

Approval is based on Phase II results from VISION, the largest interventional study to date of patients with advanced NSCLC with METex14 skipping alterations. TEPMETKO demonstrated consistent and durable responses in the VISION study.

In Europe, lung cancer is estimated to be the second most common cancer and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018. Alterations of the MET signaling pathway, including METex14 skipping alterations, are found in 3% to 4% of NSCLC cases and are associated with advanced disease and poor prognosis.