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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; lorlatinib
Trade Name: LORBRENA; 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
Pfizer, Inc.
66 Hudson Boulevard East
New York, New York 10001
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Lorlatinib; lorlatinib
Trade Name: LORBRENA; Lorbrena
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.
2 Generic Name: Lorlatinib; lorlatinib
Trade Name: LORBRENA; Lorbrena
Marketing Approval Date: 03/03/2021
Approved Labeled Indication: treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Exclusivity End Date: 03/03/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, excluding patients whose disease has progressed on crizotinib and at least one other ALK inhibitor; or alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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