Site Editor
Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Monday, February 19, 2024
On February 15, 2024, the U.S. Food & Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko) for adults with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. The kinase inhibitor was previously granted accelerated approval for this indication in 2021.
The 2021 approval was based on initial overall response rate and duration of response in the VISION trial, a multicenter, nonrandomized, open-label, multicohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess duration of response.
Efficacy was demonstrated in a total of 313 patients with metastatic NSCLC harboring MET exon skipping alterations. Patients received tepotinib at 450 mg once daily until disease progression or unacceptable toxicity.
The primary efficacy measures were determined by a blinded independent review committee. Among 164 treatment-naive patients, the overall response rate was 57% (95% confidence interval = 49%–65%), with 40% of responders having a duration of response of at least 12 months. Among 149 previously treated patients, the overall response rate was 45% (95% CI = 37%–53%), with 36% of responders having a duration of response of at least 12 months.
The most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The recommended tepotinib dose is 450 mg orally once daily with food.
Full more details, see the prescribing information.
U.S. Food & Drug Administration
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