Full Approval Granted to MET Inhibitor for Lung Cancer

The FDA has granted full approval to tepotinib for some non-small cell lung cancers that harbor a certain mutation in the MET gene. 

The U.S. Food and Drug Administration (FDA) has approved tepotinib (Tepmetko) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) that harbors a certain mutation, called an exon 14 skipping mutation, in the mesenchymal-epithelial transition (MET) gene. 

An illustration of a transparent human torso, inside of which the lungs, spine, and several gut organs are visible. The patient’s right lung contains two spherical tumors, shown in red to indicate lung cancer.
Tepotinib has been approved to treat certain non-small cell lung cancers.

Tepotinib is a tyrosine kinase inhibitor that inhibits the protein MET. MET exon 14 skipping mutations (METex14) result in an overactive form of MET that can stimulate cancer growth and metastasis. 

Tepotinib was granted an accelerated approval for this indication in February 2021. The conversion to a full approval was based on data from an extended follow-up and additional patients enrolled in the multicenter, nonrandomized, open-label, multicohort, phase II VISION trial, in which a total of 313 patients with metastatic METex14-skipping NSCLC were treated with tepotinib until disease progression or unacceptable toxicity. 

The overall response rates were 57% and 45% among patients with untreated NSCLC and patients who had received prior treatment, respectively. Among those who experienced a response, 40% of patients who had not received prior treatment and 36% of previously treated patients had responses lasting a year or longer. 

The recommended dosage for tepotinib is 450 mg once daily with food. 

NSCLC is the most common form of lung cancer, accounting for over 80% of cases. METex14-skipping mutations are estimated to occur in around 2% of all NSCLC tumors. According to federal statistics, it was estimated that 238,340 individuals would be diagnosed with lung cancer and 127,070 patients would die of the disease in the United States in 2023. 

The FDA rendered its decision on February 15, 2024.