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Novartis' Tabrecta Nets Full FDA Approval for NSCLC With METex14 Skipping Mutations

NEW YORK – The US Food and Drug Administration on Wednesday granted full approval to Novartis' Tabrecta (capmatinib) as a treatment for advanced non-small cell lung cancer patients whose tumors harbor MET exon 14 skipping alterations. 

The agency had given accelerated approval to the drug in 2020 based on the results of the Phase II GEOMETRY mono-1 trial. 

The agency converted the accelerated approval into a regular approval based on data confirming the drug's activity in an additional 63 patients and 22 more months of follow-up. In the updated analysis, 68 percent of 60 treatment-naïve patients responded to Tabrecta with a 16.6-month median duration of response, while 44 percent of 100 previously treated patients responded with a duration of response of 9.7 months. 

In Europe, the drug is approved specifically for NSCLC patients with MET exon skipping alterations who have previously received immunotherapy and/or chemotherapy, while the approvals in the US and in Japan are agnostic to prior treatment lines. 

At the time of accelerated approval, the FDA also approved Foundation Medicine's FoundationOne CDx and then later approved the FoundationOne Liquid CDx as companion diagnostics to determine METex14 skipping status in patients eligible for Tabrecta.