11 August 2022 - On August 10, 2022, the FDA granted regular approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer whose tumours have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA approved test.

Capmatinib was previously granted accelerated approval for the same indication on 6 May 2020, based on initial overall response rate and duration of response in the GEOMETRY mono-1 trial, a multicenter, non-randomised, open-label, multi-cohort study. The conversion to regular approval was based on data from an additional 63 patients, as well as an additional 22 months of follow- up time to assess durability of response and verify clinical benefit.

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