On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Read the FDA announcement.
Read Merck KGaA's announcement.