On May 22, 2020, the Food and Drug Administration (FDA) approved Alunbrig (brigatinib) for the first line treatment of advanced non-small cell lung cancer (NSCLC) with tumors having changes in ALK. The FDA based their approval on the results of the clinical trial ALTA 1L which showed that patients receiving Alunbrig (brigatinib) had a higher chance of responding well to treatment, and went longer periods of time without progression than those receiving Xalkori (crizotinib).

Alunbrig (brigatinib) being available as a first line targeted therapy option for ALK positive NSCLC gives patients access to more effective drugs in a first line setting than before.

In addition to the approval for Alunbrig (brigatinib), the FDA has approved the Vysis ALK Break Apart FISH Probe as a companion diagnostic for Alunbrig (brigatinib).

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