FDA Approves TEPMETKO for Metastatic Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) approved TEPMETKO (tepotinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

The approved recommended dosage of TEPMETKO is 450 mg orally once daily with food until disease progression or unacceptable toxicity. Select patients for treatment with TEPMETKO based on the presence of METex14 skipping alterations in plasma or tumor specimens. Testing for the presence of METex14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If an alteration is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of METex14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.

Additional information regarding dosage and administration as well as warnings and precautions about interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, and embryo-fetal toxicity can be found in the full prescribing information linked below.