FDA Approves Brigatinib for ALK-Positive NSCLC
On May 22, 2020, the FDA approved brigatinib (Alunbrig; Ariad Pharmaceuticals) for the treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non–small-cell lung cancer (NSCLC) as confirmed by an FDA-approved test.
Additionally, the FDA approve the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular) as a companion diagnostic for brigatinib.
This approval was based on efficacy outcomes from the ALTA 1L trial, in which patients with confirmed ALK-positive NSCLC, who had not received prior ALK-targeting therapy, were randomized in a 1:1 ratio to either brigatinib 180 mg orally once daily (n = 137) or crizotinib 250 mg orally twice daily (n = 138).
A subset of samples were retrospectively tested with the Vysis ALK Break Apart FISH Probe Kit. Of 275 patients enrolled on the trial, 239 had positive results using the companion diagnostic test.
The main efficacy outcome was progression-free survival (PFS). Secondary efficacy outcomes included confirmed overall response rate (ORR).
The estimated median PFS for patients receiving brigatinib was 24 months (95% CI, 18.5, NE) compared with 11 months (95% CI, 9.2, 12.9) for those receiving crizotinib (HR, 0.49; 95% CI, 0.35, 0.68; P <.0001). Additionally, the confirmed ORR was 74% (95% CI, 66, 81) and 62% (95% CI, 53, 70) for each group, respectively.
The most common adverse events (≥25%) associated with brigatinib were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.—Janelle Bradley
Source: US Food and Drug Administration. FDA approves brigatinib for ALK-positive metastatic NSCLC. May 22, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-brigatinib-alk-positive-metastatic-nsclc. Accessed May 26, 2020.
