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Brigatinib Approval Status

Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

Development Status and FDA Approval Process for brigatinib

DateArticle
Oct 31, 2016ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib
Aug 30, 2016ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA
Jun 17, 2016ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. FDA Ahead of Plan
Apr 15, 2016ARIAD Presents Updated Phase 1/2 Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer
Apr 17, 2015ARIAD Presents Updated Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer

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