European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations.- Merck KGaA.

Merck KGaA, 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. With this validation, the application is complete, and the EMA will now begin the review procedure. Tepotinib is a highly selective oral MET inhibitor that is administered once daily. The application to EMA is based on results from the pivotal Phase II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy (LBx) or tissue biopsy (TBx). In the ongoing study, the patient population is generally characterized as elderly, with a median age of 74.0 years, and as having poor clinical prognosis typical of NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) on May 29, 2020. Lung cancer is estimated to be the second most common cancer in Europe, and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018. METex14 skipping occurs in approximately 3–4% of NSCLC cases and correlates with aggressive tumor behavior and poor clinical prognosis. Currently, there are no treatments available in Europe for patients with advanced NSCLC harboring METex14 skipping alterations.Tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with its approval in Japan in March 2020 through the SAKIGAKE program. Recently, the FDA granted Orphan Drug Designation (ODD) to tepotinib and the FDA is reviewing the application under Priority Review and through the Real-Time Oncology Review pilot program.