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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Lorlatinib
Trade Name:  LORBRENA
Date Designated:  06/23/2015
Orphan Designation:  Treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/02/2018 
Approved Labeled Indication:  LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Exclusivity End Date:    11/02/2025 
Exclusivity Protected Indication* :  LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Pfizer, Inc.
235 East 42nd Street (M/S 219/9/30)
New York, New York 10017
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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