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FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Oct 31, 2016

Paris Panayiotopoulos

Paris Panayiotopoulos

The FDA has has granted a priority review to a new drug application (NDA) for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori), according to a statement from the drug's developer, Ariad Pharmaceuticals.

The phase III ALTA-1L study has been initiated to compare brigatinib with crizotinib as a frontline therapy for patients with ALK-positive NSCLC. This study is assessing the 180-mg regimen of brigatinib (NCT02737501).
Kim D-W, Tiseo M, Ahn M-J, et al. Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): First report of efficacy and safety from a pivotal randomized phase (ph) 2 trial (ALTA). J Clin Oncol. 2016;34 (suppl; abstr 9007).

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