The European Medicines Agency (EMA) has validated Merck’s application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) 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.
Tepotinib is a highly selective oral MET inhibitor that is administered once daily.1 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.
Tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harbouring 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.