FDA approves capmatinib and companion assay for metastatic NSCLC

  • FDA
  • 6 May 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Key highlights

  • 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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