FDA approves Tepmetko for metastatic NSCLC subset
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The FDA granted accelerated approval to tepotinib for treatment of certain patients with metastatic non-small cell lung cancer.
The approval applies to use of the agent for adults whose tumors harbor mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Tepotinib (Tepmetko, Merck/EMD Serono) is an oral MET kinase inhibitor.
The FDA based the approval on results of the nonrandomized phase 2 VISION trial. The multicenter, open-label, multicohort study included 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations.
Patients received tepotinib dosed at 450 mg orally once daily. Treatment continued until disease progression or unacceptable toxicity.
Overall response rate as assessed by blinded independent review committee and duration of response served as the main efficacy outcomes.
In the subgroup of 69 treatment-naive patients, researchers reported an ORR of 43% (95% CI, 32-56) and a median response duration of 10.8 months (95% CI, 6.9-not estimable). In the subgroup of 83 previously treated patients, researchers reported an ORR of 43% (95% CI, 33-53) and a median response duration of 11.1 months (95% CI, 9.5-18.5).
The most common adverse events reported among tepotinib-treated patients included edema, fatigue, nausea, diarrhea, musculoskeletal pain and dyspnea. Tepotinib also can cause interstitial lung disease, hepatotoxicity and embryo-fetal toxicity, according to FDA.
The FDA evaluated tepotinib for this indication under its Real-Time Oncology Review pilot program, designed to accelerate the delivery of effective and safe cancer treatments to patients.
Last summer, FDA granted priority review designation to tepotinib for this indication.
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