Jesus Gomez Navarro, MD
Brigatinib (Alunbrig) reduced the risk of disease progression or death versus crizotinib (Xalkori) in adult patients with locally advanced or metastatic ALK
-positive non–small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor, meeting the primary endpoint of the phase III ALTA-1L trial.
The FDA granted brigatinib an accelerated approval in April 2017 for the treatment of patients with metastatic ALK
-positive NSCLC who are resistant to prior crizotinib. Accelerated approvals are contingent upon results from subsequent confirmatory trials.
The accelerated approval was based on findings from the phase II ALTA trial, in which the confirmed ORR for brigatinib at 180 mg daily was 53% (95% CI, 43-62) and the median PFS was 13.8 months.
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