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. |
| Sponsor: |
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. |
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