FDA Approves Tepmetko (tepotinib) for People with Metastatic Non-Small Cell Lung Cancer with MET-Exon 14 Mutation

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On Feb. 15, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval of Tepmetko (tepotinib) for people living with metastatic non-small cell lung cancer (NSCLC) with a MET-Exon 14 mutation. Tepmetko (tepotinib) initially received accelerated approval in 2021 based on initial results from the VISION study, which evaluated the use of Tepmetko (tepotinib) in people with metastatic NSCLC with a MET-Exon 14 skipping mutation.The new traditional (not accelerated) approval is based on the inclusion of an additional cohort of study participants and an additional 28 months of study follow-up. The expanded results showed a meaningful response rate and duration of response with Tepmetko (tepotinib) for both people who have previously received treatment and people receiving treatment for the first time. While this treatment was already approved for people with NSCLC with a MET-Exon 14 mutation, this new approval confirms who may benefit from this treatment and what outcomes they can expect.Read more about the approval here:fda.gov/drugs/resources-inf...