FDA approves capmatinib for MET exon 14-mutated NSCLC
medwireNews: US patients with metastatic non-small-cell lung cancer (NSCLC) carrying MET exon 14 skipping mutations can now receive the selective MET inhibitor capmatinib following a positive US FDA decision.
The FDA also approved a companion diagnostic test – the FoundationOne CDx assay (Foundation Medicine, Inc, Cambridge, Massachusetts, USA) – to detect the presence of the specific MET mutations.
The decision is based on the findings of the phase 2 GEOMETRY mono-1 trial that showed objective response rates of 68% and 41% among treatment-naïve and previously treated participants, respectively.
Noting that capmatinib has been associated with phototoxicity in preclinical studies, the FDA advises patients to cover their skin, use sunscreen, and not tan while they are taking capmatinib.
The recommended dose for the orally administered MET inhibitor is 400 mg twice a day.
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