FDA approves brigatinib for ALK-positive mNSCLC

  • FDA

  • von Kelli Whitlock Burton
  • Studien – kurz & knapp
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Takeaway

  • The FDA has approved brigatinib for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.
  • The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib.

Why this matters

  • Brigatinib was granted priority review and orphan drug designation.

Key points

  • Recommended brigatinib dose is 90 mg orally once daily for the first 7 days, increased to 180 mg orally once daily.
  • No contraindications, but dose modifications are recommended for patients receiving strong or moderate CYP3A inhibitors or inducers or with severe hepatic or renal impairment.
  • Approval based on a randomized, open-label, multicenter ALTA-1L trial:
    • 137 patients received brigatinib; 138 received crizotinib.
    • Estimated median PFS was significantly higher for the brigatinib group (24 vs 11 months; HR, 0.49; P<.0001>
    • Confirmed objective response rate was 74% with brigatinib vs 62% with crizotinib (P=.0342).
    • 51% of the brigatinib group and 30% of the crizotinib group had a response duration ≥24 months.
  • The most common adverse events with brigatinib included diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.

Prescribing info.