Search Orphan Drug Designations and Approvals
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Generic Name: | lorlatinib | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Pfizer, Inc. 235 East 42nd Street New York, New York 10017 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | lorlatinib |
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Trade Name: | 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 |
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Trade Name: | 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. | |
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