- The US Food and Drug Administration (FDA) has approved capmatinib for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping mutations.
- The recommended dose is 400 mg orally twice daily with or without food.
- FDA has also approved the FoundationOne CDx assay, a companion diagnostic test that detects several mutations, including MET exon 14 skipping mutations.
Why this matters
- Capmatinib, a selective reversible inhibitor of MET tyrosine kinase, is the first approved treatment for NSCLC with MET exon 14 skipping mutation.
- The approval was based on the phase 2 GEOMETRY mono-1 trial.
- 97 patients (69 previously treated and 28 treatment-naive) received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.
- Treatment-naive patients and previously treated patients, respectively, had:
- Overall response rates: 68% and 41%; and
- Median durations of response: 12.6 and 9.7 months.
- The most common adverse reactions (≥20%) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
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