EMA validates tepotinib for unserved NSCLC patients

26 November 2020

Germany’s Merck KGaA (MRK: DE) has announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

The EMA will now begin the review procedure of tepotinib, a highly selective oral MET inhibitor that is administered once daily. Discovered and developed in-house at Merck, it is seen as having the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.

This application to the EMA is based on results from the pivotal Phase II VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations.

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