- 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.
- 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.