A Once-A-Day Targeted Therapy Tablet for Advanced Lung Cancer

The FDA granted accelerated approval to a new oral targeted therapeutic to treat certain adult patients with the most common form of lung cancer.

The U.S. Food and Drug Administration has granted accelerated approval to the molecularly targeted agent tepotinib (Tepmetko) to treat adult patients with metastatic non-small cell lung cancer whose tumors have alterations in the mesenchymal-epithelial transition (MET) gene signaling pathway, called METex14 skipping alterations. Specifically, tepotinib is designed to block the activity of proteins made by METex14 skipping alterations. 

The data to demonstrate the efficacy of tepotinib was collected in a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic non-small cell lung cancer with METex14 skipping alterations. Among the 69 study participants who had not received any previous treatment, the overall response rate was 43 percent, with a median response that lasted 10.8 months. Among the 83 participants who had received previous treatment, the overall response rate was 43 percent, with a median response duration of 11.1 months. 

Tepotinib was approved as a once-a-day pill. In 2020, another oral agent to be taken twice a day was approved for patients with metastatic disease harboring METex14 skipping alterations. According to experts, this mutation is found in approximately 3 to 4 percent of non-small cell lung cancers. Non-small cell lung cancer accounts for more than 80 percent of all cases of lung cancer. 

Lung cancer remains the number one cause of cancer death among men and women, both in the U.S. and globally.  

Tepotinib was granted accelerated approval by the FDA on February 3, 2021. Accelerated approval means continued approval may be contingent upon a confirmatory trial.