15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic non-small-cell lung cancer harbouring mesenchymal-epithelial transition exon 14 skipping alterations.

Tepotinib was previously granted accelerated approval for this indication on 3 February 2021, based on initial overall response rate and duration of response in the VISION trial, a multi-centre, non-randomised, open-label, multi-cohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess duration of response.

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