Tepotinib Granted Accelerated Approval by FDA in Metastatic NSCLC
Posted: Friday, February 5, 2021
On February 3, the U.S. Food and Drug Administration granted accelerated approval to the kinase inhibitor tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.
Efficacy was demonstrated in the VISION trial (ClinicalTrials.gov identifier NCT02864992), a multicenter, nonrandomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14–skipping alterations. Patients received tepotinib at 450 mg orally once daily until disease progression or unacceptable toxicity.
The main efficacy outcome measures were overall response rate, determined by a blinded independent review committee using Response Evaluation Criteria in Solid Tumors version 1.1, and response duration. Among the 69 treatment naive patients, the overall response rate was 43% (95% confidence interval [CI] = 32%–56%), with a median response duration of 10.8 months (95% CI = 6.9 months to not estimable). Among the 83 previously treated patients, the overall response rate was 43% (95% CI = 33%–55%), with a median response duration of 11.1 months (95% CI = 9.5–18.5 months).
The most common adverse reactions (≥ 20% of patients) were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Tepotinib can also cause interstitial lung disease, hepatotoxicity, and embryofetal toxicity.
The recommended tepotinib dose is 450 mg orally once daily with food.
For full prescribing information for tepotinib, visit accessdata.fda.gov.