FDA grants full approval for Tabrecta in metastatic NSCLC

The US Food and Drug Administration (FDA) has granted regular approval to Swiss pharma giant Novartis’ (NOVN: VX) Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping.

Capmatinib was previously granted accelerated approval for the same indication on May 6, 2020, based on initial overall response rate and duration of response in the GEOMETRY mono-1 trial, a multicenter, non-randomized, 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.

Conditional approval has been granted by the FDA to a large number of marketing applications in the USA. However, this is dependent on additional data being provided by the drug originator, which a number of drugmakers have failed to provide, so the conditional approvals have been retracted.