2020: Brigatinib Use Expanded

On This Day in Health: May 22, 2020

On May 22, 2020, the U.S. Food and Drug Administration expanded the approved use of brigatinib, sold as Alunbrig, for adults with ALK-positive metastatic non-small cell lung cancer. The decision included the first-line setting, allowing the medicine to be considered without requiring prior treatment with another ALK inhibitor. Brigatinib had already entered U.S. care for patients whose cancer had worsened on crizotinib or who could not tolerate it. The anniversary therefore marks an expansion of an existing medicine's role. That distinction matters because earlier access after one treatment fails and access at the beginning of a treatment sequence are different milestones.

ALK alterations can help drive the growth of a subset of lung cancers. Brigatinib is an oral tyrosine kinase inhibitor designed to interfere with that signaling. The approved indication required ALK-positive disease detected by an FDA-approved test. As with other targeted treatments, the location of the cancer alone did not establish eligibility. The molecular result helped connect the patient to the evidence behind the drug. This approach made laboratory testing central to treatment planning and showed how a classification based on the tumor's biology could lead to a different set of choices than a broad organ-based diagnosis would suggest.

The expansion was supported by ALTA-1L, a randomized study involving 275 patients who had not previously received an ALK inhibitor. Investigators compared brigatinib with crizotinib and assessed the time before disease progression or death. The results favored brigatinib on that measure, helping support its movement into the first-line setting. Evidence about disease control did not remove the need to assess adverse effects. The medicine carried warnings including lung inflammation, hypertension, slow heart rate and other complications. Although taking an oral medicine can change the practical routine of care, it still requires careful prescribing, monitoring and review of symptoms rather than simply replacing clinical visits with a daily tablet.

The historical importance of May 22 lies partly in treatment order. A medicine can be available for years yet acquire a new role when a study shows how it performs earlier in care. For people newly facing metastatic ALK-positive lung cancer, the decision widened the first conversation about options. For researchers, it demonstrated the value of a direct comparison with an established treatment. The anniversary is strongest when those features remain clear: an existing targeted drug, a defined molecular population and evidence supporting a broader place in the sequence. It recognizes progress in the choices available to patients while keeping attention on the ongoing work of choosing and managing the treatment appropriately.