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FDA Approves Brigatinib for ALK-Positive Metastatic NSCLC


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On May 22, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.

The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib.

ALTA-1L

The efficacy of brigatinib was investigated in the ALTA-1L study, a randomized, open-label, multicenter trial in adult patients with advanced ALK-positive NSCLC who had not previously received an ALK-targeted therapy. The trial required patients to have an ALK rearrangement based on a local standard-of-care testing.

The trial randomly assigned 275 patients to receive brigatinib at 180 mg orally once daily with a 7-day lead-in at 90 mg once daily (n = 137), or crizotinib at 250 mg orally twice daily (n = 138). A subset of the clinical samples was retrospectively tested with the Vysis ALK Break Apart FISH Probe Kit. Of the enrolled patients, 239 had positive results using the Vysis diagnostic test (central results were negative for 20 patients and unavailable for 16 patients).

The major efficacy outcome measure was progression-free survival evaluated by a blinded independent review committee according to Response Evaluation Criteria in Solid Tumors, version 1.1. An additional efficacy outcome measure as evaluated by the committee was confirmed overall response rate.

Estimated median progression-free survival for patients treated with brigatinib was 24 months (95% confidence interval [CI] = 18.5–not evaluable) compared with 11 months (95% CI = 9.2–12.9) for those treated with crizotinib (hazard ratio = 0.49, 95% CI = 0.35–0.68, P < .0001). The confirmed overall response rate was 74% (95% CI = 66%–81%) and 62% (95% CI = 53%–70%), respectively.

The most common adverse reactions (≥ 25%) reported in patients treated with brigatinib were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.

The recommended brigatinib dose is 90 mg orally once daily for the first 7 days, then increased to 180 mg orally once daily. Brigatinib may be taken with or without food.


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