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FDA Grants Brigatinib Priority Review for Frontline ALK+ NSCLC

Jason M. Broderick
Published: Monday, Feb 24, 2020

The FDA has granted a priority review designation to a supplemental New Drug Application (sNDA) for brigatinib (Alunbrig) for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.1

The sNDA is based on the phase III ALTA-1L trial, in which treatment with brigatinib demonstrated a 57% reduction in the risk of disease progression or death compared with crizotinib (Xalkori) in patients with advanced ALK-positive NSCLC who had not received a prior ALK inhibitor.2,3

The 2-year investigator-assessed results, which were presented during the 2019 ESMO Asia Congress, showed that brigatinib led to a 76% (HR, 0.24; 95% CI, 0.12-0.45) reduction in the risk of disease progression or death in newly diagnosed patients who had brain metastases at time of enrollment.

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