First Comprehensive Genomic Profiling Assay Approved for Use with Brigatinib, ALK-positive NSCLC

First Comprehensive Genomic Profiling Assay Approved for Use with Brigatinib, ALK-positive NSCLC

Industry News & Regulatory Approvals
Jul 01, 2021
Regulatory Approval

July 1, 2021—The U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx for use as a companion diagnostic for brigatinib, which the FDA had previously approved for treatment of adult patients with ALK-positive NSCLC. FoundationOne CDx is a tissue-based comprehensive genomic profiling assay and is the first of this kind to receive FDA approval. It can be used to identify patients with ALK-positive NSCLC who are candidates for treatment with brigatinib.

The FDA’s May 2020 approval of brigatinib as first-line treatment was based on ALTA-1L (NCT02737501), an open-label phase III trial that enrolled 275 adult patients with locally advanced or metastatic ALK-positive NSCLC and at least one measurable lesion who had no prior ALK-targeted treatment. Participants received either 180 mg of brigatinib daily (with a 7-day lead-in of 90 mg once daily) or 250 mg of crizotinib twice-daily, until disease progression or unacceptable toxicity.

The median PFS was 24.0 months (95% CI: 18.5, NE) for the brigatinib arm and 11.0 months (95% CI: 9.2, 12.9) for the crizotinib arm (HR, 0.49; 95% CI: 0.35, 0.68; p < 0.0001). Confirmed ORR was 74% (95% CI: 66%, 81%) and 62% (95% CI: 53%, 70%), respectively. The most frequent adverse events of any grade were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.

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