EU approves Tepmetko as monotherapy in NSCLC with METex14 mutations.- Merck KGaA
Merck KGaA 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.
The approval is based on results from the pivotal Phase II VISION study evaluating Tepmetko as monotherapy in patients with advanced NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were previously published online in The New England Journal of Medicine.
VISION is an ongoing pivotal Phase II, multicenter, multi-cohort, single-arm, non-randomized, open-label study investigating tepotinib as monotherapy. Based on the 01 February 2021 data cut, 275 patients with a median age of 72.6 years with advanced or metastatic NSCLC with METex14 skipping alterations have been analyzed.
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