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Alunbrig Approval History

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 anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

Development History and FDA Approval Process for Alunbrig

DateArticle
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
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

Further information

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