Tepmetko Gets Traditional Approval for MET Exon 14-Skipping NSCLC

The Food and Drug Administration (FDA) has granted traditional approval to Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 (METex14) skipping alterations.

The kinase inhibitor was previously approved for this indication under the FDA’s accelerated pathway based on overall response rate (ORR) and duration of response (DOR) observed in the phase 2 VISION trial (ClinicalTrials.gov Identifier: NCT02864992). Data from an additional 161 patients, as well another 28 months of follow up, resulted in the conversion to traditional approval.

In the VISION study, participants with metastatic NSCLC harboring METex14 skipping alterations (N=313) received tepotinib 450mg once daily until disease progression or unacceptable toxicity. Findings showed that among treatment-naïve patients (n=164), the ORR was 57% (95% CI, 49-65); 40% of responders had responses lasting at least 12 months. Among previously treated patients (n=149), the ORR was 45% (95% CI, 37-53); 36% of responders had responses lasting at least 12 months.

Edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash were reported as the most common adverse reactions. 

Tepmetko is supplied as 225mg strength tablets. The recommended dosage is 450mg orally once daily with food until disease progression or unacceptable toxicity.

This article originally appeared on MPR