Lung CancerFDA Approvals, News & Updates

FDA Approves Tepmetko, New Targeted Therapy, for Patients with Metastatic Lung Cancer and MET Exon 14 Alterations

In February 2021, the FDA approved Tepmetko (tepotinib), a new oral targeted therapy, for the treatment of all adults with metastatic non–small-cell lung cancer and MET exon 14 alterations. Tepmetko is the second MET inhibitor that has been approved by the FDA.
February 2021 Vol 7 No 1

In February 2021, the FDA approved Tepmetko (tepotinib; from EMD Serono), a new oral targeted therapy, for the treatment of adults diagnosed with metastatic non–small-cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. This new tablet is appropriate for patients who have not received any previous therapy as well as for patients who have received previous therapy.

Tepmetko is the second MET inhibitor that has been approved by the FDA. It should be selected for treatment after the patient has had a genetic testing showing the presence of METex14 skipping alterations.

METex14 skipping occurs in approximately 3% to 4% of NSCLC cases, and patients with this aggressive lung cancer are often elderly and face a poor clinical prognosis,” said Paul K. Paik, MD, lead investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY. “There is a pressing need for targeted treatments that have the potential to generate durable anti-tumor activity and improve the lives of patients with this challenging disease.”

“The availability of a new precision medicine for NSCLC with METex14 skipping alterations advances patient access to targeted treatment and underscores the importance of routine comprehensive biomarker testing for patients with this challenging cancer,” said Andrea Ferris, LUNGevity President and CEO.

The FDA approved Tepmetko based on the results from a clinical trial that included 152 patients with advanced or metastatic NSCLC and METex14 skipping alterations. In all, 69 patients had not received previous therapy and 83 patients had received previous therapy. In the study, all patients received skipping treatment with Tepmetko tablets once daily, until their disease progressed or until they had unacceptable side effects. The main efficacy outcome measures were overall response rate and duration of response.

Among the 69 who had not received previous treatment for lung cancer, 43% of the patients had a response to treatment with Tepmetko, and the average duration of response was 10.8 months. Similarly, among the 83 patients who received previous treatment, 43% of the patients had a response to treatment with Tepmetko, and the average duration of response was 11.1 months.

The most common side effects with Tepmetko were swelling, fatigue, nausea, diarrhea, musculoskeletal pain, and difficulty breathing.

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Last modified: March 12, 2021

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