The Food and Drug Administration has granted an accelerated approval to Tepmetko for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose disease harbors mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
The Food and Drug Administration (FDA) on Wednesday granted Tepmetko (tepotinib) an accelerated approval for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose disease harbors mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
The agency’s decision was based on data from a multicenter, open label, multicohort study.
In the VISION trial, 152 patients with advanced or metastatic NSCLC whose disease harbored MET exon 14 skipping alterations. Patients enrolled on trial received tepotinib 450 mg orally once daily until their disease progressed or they could no longer tolerate toxicities.
Measuring overall response rate (the proportion of patients who have a partial or complete response to therapy) was the main goal of the trial. Among patients who had never received prior treatment (69 patients), Tepmetko induced an overall response rate of 43% and a median duration of response of 10.8 months. The remaining 83 patients who had previously received treatment prior to enrollment achieved an overall response rate of 43% and a median duration of response of 11.1 months.
The most common side effects to occur in more than 20% of patients included edema (swelling), nausea, diarrhea, musculoskeletal pain and shortness of breath. The agency noted that treatment with Tepmetko may cause interstitial lung disease (progressive scarring of lung tissue), hepatotoxicity (liver injury), and embryo-fetal toxicity (birth defects).
The agency recommends patients receive Tepmetko at 450 mg orally once a day with food.