Posted by Michael Wonder on 26 Nov 2020
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations
26 November 2020 - Merck today announced that the EMA has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
With this validation, the application is complete, and the EMA will now begin the review procedure.
The application to EMA is based on results from the pivotal Phase 2 VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy.
