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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  brigatinib; brigatinib
Trade Name:  Alunbrig; Alunbrig
Date Designated:  04/28/2016
Orphan Designation:  Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC).
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/28/2017 
Approved Labeled Indication:  Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Exclusivity End Date:    04/28/2024 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  brigatinib; brigatinib
Trade Name:  Alunbrig; Alunbrig
Date Designated:  04/28/2016
Orphan Designation:  Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC).
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/22/2020 
Approved Labeled Indication:  ALUNBRIG (brigatinib) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Exclusivity End Date:    05/22/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, not including patients who have progressed on or are intolerant to crizotinib.
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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