FDA Approves Tepotinib for Metastatic NSCLC With MET Exon 14 Skipping Alterations
Tepotinib has received a traditional approval from the FDA for metastatic NSCLC with MET exon 14 skipping alterations, updating the previous accelerated approval from 2021.
FDA Approves Tepotinib for Metastatic NSCLC With MET Exon 14 Skipping Alterations
The FDA has approved tepotinib (Tepmetko) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Of note, this is a traditional approval, as tepotinib was previously granted accelerated approval by the FDA in 2021. The accelerated approval was based on the initial overall response rate (ORR) and duration of response (DOR) from the VISION trial (NCT02864992). The traditional approval just granted by the FDA was based on findings from an additional 161 patients and 28 additional months of follow-up for DOR, according to an alert from the agency.
In total, 313 patients with metastatic NSCLC harboring MET exon skipping alterations were assessed to determine tepotinib’s efficacy. Patients were treated with 450 mg of tepotinib once per day until disease progression or unacceptable toxicity.
The primary efficacy measures of the VISION trial were DOR and ORR, as determined by a Blinded Independent Review Committee. Of the 164 patients who were treatment-naive, the ORR was 57% (95% CI, 49%-65%). Of the patients with an objective response to treatment, 40% had a DOR of at least 12 months. For the 149 patients who were previously treated, the ORR was 45% (95% CI, 37%-53%), of whom 36% had a DOR of at least 12 months.
The most common adverse reactions, occurring in at least 20% of patients in the VISION trial, included nausea, edema, musculoskeletal pain, fatigue, dyspnea, diarrhea, rash, and decreased appetite, according to the alert.
The FDA recommends a 450-mg dose for tepotinib to be taken orally once per day with food.
Reference
FDA approves tepotinib for metastatic non-small cell lung cancer. FDA. February 13, 2024. Accessed February 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer
