LORBRENA (lorlatinib)
LORBRENA is indicated for the treatment of Non-Small Cell Lung Cancer.
How LORBRENA Works
Lorlatinib is a third-generation tyrosine kinase inhibitor (TKI) with potent activity against ALK and ROS1. It was specifically engineered to cross the blood-brain barrier and to maintain efficacy against a wide range of ALK resistance mutations, including the G1202R "solvent front" mutation that often develops after treatment with first- and second-generation TKIs. By inhibiting ALK phosphorylation and downstream signaling pathways, lorlatinib induces apoptosis and inhibits tumor growth in both systemic and central nervous system (CNS) lesions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-02
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
LORBRENA Approval History
What LORBRENA Treats
1 indicationsLORBRENA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
LORBRENA Target & Pathway
ProTarget
A receptor tyrosine kinase that, when mutated or rearranged, drives cancer cell growth. ALK rearrangements occur in about 5% of non-small cell lung cancers. Inhibiting ALK blocks aberrant signaling that promotes tumor survival and proliferation.
LORBRENA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LORBRENA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LORBRENA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LORBRENA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07415005 | 2025-1552 NCI-2026-01061 | Ph 2 | recruiting | Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer |
| NCT03737994 results posted | NCI-2018-02486 NCI-2018-02486, NRG-LU003 | Ph 2 | terminated | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer |
| NCT06282874 | CTONG2303 | Ph 4 | active not recruiting | Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases |
| NCT06007937 | 23-131 | Ph 1, Ph 2 | recruiting | A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT05740943 | LORIN | Ph 2 | active not recruiting | Induction Lorlatinib in Stage III Non-small Cell Lung Cancer |
| NCT05297890 | CS3011-201 | Ph 2 | active not recruiting | A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer |
| NCT05144997 | B7461039 2023-508952-21-00 | Ph 4 | active not recruiting | Lorlatinib Continuation Study |
| NCT03052608 results posted | B7461006 2023-509169-19-00 | Ph 3 | active not recruiting | A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC |
| NCT03909971 results posted | B7461024 NCT03909971 | Ph 2 | completed | A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China |
| NCT04621188 | IFCT-2003 2024-512028-12-00 | Ph 2 | active not recruiting | Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) |
| NCT03107988 results posted | NANT2015-02 | Ph 1 | completed | NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) |
| NCT04362072 results posted | B7461027 2019-002504-41 | Ph 4 | completed | Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer |
| NCT04111705 ORAKLE | IFCT-1902 | Ph 2 | completed | Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer |
| NCT06893354 | LORLAL-001-V1 | Ph 4 | not yet recruiting | Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics |
| NCT06858410 | CTONG2403 | Ph 3 | not yet recruiting | Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma |
| NCT05097599 StrataPATH | STR-004-001 KEYNOTE-F04 | Ph 2 | terminated | StrataPATH™ (Precision Indications for Approved Therapies) |
| NCT04541706 results posted | B7461030 | Ph 4 | completed | Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India |
| NCT04127110 ALKALINE | EORTC-1825 2019-003862-41 | Ph 2 | active not recruiting | Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients |
| NCT04800822 | C4481001 2022-502431-18-00, 2022-003166-21 | Ph 1 | terminated | PF-07284892 in Participants With Advanced Solid Tumors |
| NCT05224609 | B7461040 | Ph 1 | completed | A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction |
| NCT03726333 results posted | B7461009 lorlatinib HEPATIC IMPAIRMENT, HEPATIC IMPAIRMENT | Ph 1 | terminated | Hepatic Impairment Study for Lorlatinib in Cancer Patients |
| NCT06378892 ALK-PPL | CRO-2023-78 | Ph 2 | recruiting | A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT05948462 NSCLC | LUN 481 | Ph 2 | withdrawn | Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib |
| NCT03542305 results posted | B7461010 RENAL IMPAIRMENT | Ph 1 | completed | Lorlatinib Renal Impairment Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LORBRENA FDA Label Details
Indications & Usage
FDA Label (PDF)LORBRENA is indicated for the treatment of Non-Small Cell Lung Cancer.
LORBRENA Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LORBRENA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 20 active patents
Trial Analysis
- • 31 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment