FDA Approves Tepotinib for Adults With Metastatic NSCLC
On February 3, 2021, the FDA approved tepotinib (Tepmetko; EMD Serono) for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) with MET exon 14 skipping alterations.
This approval was based on the multi-center, non-randomized, open-label VISION clinical trial of patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations.
A total of 152 patients were enrolled in the study and given tepotinib 450 mg once daily until disease progression or unacceptable toxicity occurred.
The main efficacy end points were overall response rate (ORR) and duration of response (DoR). Among 69 treatment-naïve patients, the ORR was 43% (95% CI, 32%-56%) with a median DoR of 10.8 months (95% CI, 6.9 to not estimable).
Among 83 previously treated patients, the ORR was 43% (95% CI, 33%-55%) with a median DoR of 11.1 months (95% CI, 9.5-18.5).
The most common (≥20%) adverse events were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity have also been associated with tepotinib use.—Hina Porcelli
Source: US Food and Drug Administration. FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer. February 3, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer. Accessed February 3, 2021.