Treats metastatic non-small cell lung cancer (NSCLC). Sold as Lorbrena. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Lorlatinib (sold as Lorbrena), first approved Nov 2, 2018, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Lorbrena | Part D | $207M | +77% | 1,460 |
| Shortage | Status | First posted | Updated |
|---|---|---|---|
| Lorlatinib Tablet | To Be Discontinued | Jun 15, 2026 | Jun 15, 2026 |
| TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-SamplingNon-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung) · Karolinska Institutet | Not applicable | Not yet recruiting | Sep 16, 2026 |
| Study of NXP900 With Lorlatinib in ALK+ Lung CancerALK Positive, ALK Positive Non-small Cell Lung Cancer · Nuvectis Pharma, Inc. | Phase 1 | Recruiting | Aug 25, 2026 |
| Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving LorlatinibLung Cancer · University of Chicago | Phase 1 | Recruiting | Aug 24, 2026 |
| Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLCALK Positive Non-small Cell Lung Cancer · Guangdong Association of Clinical Trials | Phase 2 | Not yet recruiting | Aug 6, 2026 |
| Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / MixedALK Fusion-positive Non-small Cell Lung Cancer · Hunan Cancer Hospital | Phase 4 | Not yet recruiting | Jun 29, 2026 |
| Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLCNon-Small Cell Lung Cancer (NSCLC), Hyperlipidemia · Sun Yat-sen University | — | Not yet recruiting | Jun 29, 2026 |
| Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLCALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib · Qiming Wang | Phase 4 | Not yet recruiting | Jun 26, 2026 |
| OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic TherapyBrain Metastasis, Stereotactic Radiosurgery · M.D. Anderson Cancer Center | Phase 1 | Recruiting | Jun 18, 2026 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA