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Alunbrig FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved April 28, 2017)
Brand name: Alunbrig
Generic name: brigatinib
Dosage form: Tablets
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Development timeline for Alunbrig

May 22, 2020Approval FDA Approves Takeda‚Äôs Alunbrig (brigatinib) as a First-Line Treatment Option for Patients with ALK+ Metastatic Non-Small Cell Lung Cancer (NSCLC)
Apr 28, 2017Approval Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib)
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

Further information

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