On February 3, 2021, EMD Serono, a subsidiary of Merck, Germany, announced that the U.S. Food and Drug Administration (FDA) has approved the oral MET inhibitor tepotinib (trade name: TEPMETKO) to be used for the treatment of MET gene penetrance 14 Adult patients with metastatic non-small cell lung cancer (NSCLC) with skip mutations (MET ex14).

　　Tepotinib is an oral MET inhibitor, independently developed by Merck, Germany, aimed at inhibiting the oncogenic MET receptor signal caused by MET gene mutation. The FDA has previously granted tepotinib breakthrough therapy designation and approved its listing through the Real-Time Oncology Review (RTOR) program. In March 2020, it was approved for marketing in Japan. It is an oral MET inhibitor approved by regulatory authorities for the treatment of advanced NSCLC with MET gene mutations. Recently, the FDA also granted tepotinib orphan drug designation (ODD).

　　In July 2013, Merck submitted a clinical application to the National Medical Products Administration (NMPA) in China, and is currently conducting 4 clinical studies in China.

　　Dr. Paul K. Paik, researcher and clinical director of the Thoracic Oncology Department of Memorial Sloan-Kettering Cancer Center, said: "MET ex14 jump mutations account for 3% to 4% of NSCLC cases. Patients with this aggressive lung cancer are usually elderly people. The prognosis is poor. At present, there is an urgent clinical need for targeted therapy that can produce anti-tumor activity to improve the lives of patients with this challenging disease. Tepotinib provides a new treatment option for patients with metastatic non-small cell lung cancer who carry this gene mutation. "

　　Lung cancer is a common malignant tumor in the human body, which seriously threatens people's lives. It is one of the common types of cancer and the main cause of cancer-related deaths. Changes in the MET signaling pathway, including MET exon 14 skipping mutations and MET amplification, have been found in many types of cancer, including NSCLC, which may be related to tumor aggressive behavior and poor clinical prognosis.

　　Congratulations to Merck's MET inhibitor for being approved by the FDA. Its arrival will bring new treatment options and hope to patients with non-small cell lung cancer.