Lorbrena
An oral targeted therapy used to treat ALK-positive advanced non-small cell lung cancer.
Where Lorlatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Lorlatinib was the US, on 2 Nov 2018. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Lorlatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lorlatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 4 Oct 2038 (US 11299500).
- Latest patent on the drug substance itself: 4 Oct 2038 (US 11299500).
- Exclusivity ODE-349: Orphan drug exclusivity: treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphom…, until 3 Mar 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lorlatinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Lorlatinib works
All drug targets →- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- EML4-ALK inhibitor InhibitorTarget: EML4-ALK✓ In ChEMBL and the Guide to Pharmacology
- Inhibits ROS1 Primary targetTarget: ROS1 ROS proto-oncogene 1, receptor tyrosine kinaseGuide to Pharmacology only
- GanglioneuroblastomaPhase 3
- Lung adenocarcinomaPhase 3
- NeuroblastomaPhase 3
- MetastasisPhase 2
- Non-Hodgkin lymphomaPhase 2
- Plasma cell myelomaPhase 2
- Thyroid gland carcinomaPhase 2
- Lung cancerPhase 1/2
- Hematopoietic and lymphoid cell neoplasmPhase 1
- Diffuse intrinsic pontine gliomaEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3286830, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7476, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Lorlatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Lorlatinib. 2 are current, and 2 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lorlatinib for ALK-positive advanced non-small-cell lung cancer that has not been treated with an ALK inhibitor NICE TA1103 | Recommended | 21 Oct 2025 | Current |
| Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer NICE TA628 | Recommended | 13 May 2020 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Lorlatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LorviquaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Lorlatinib
- ATC code
- L01XE44
- ChEMBL
- CHEMBL3286830
- DrugBank
- DB12130
- PubChem CID
- 71731823
- CAS number
- 1454846-35-5
- FDA UNII
- OSP71S83EU
- Wikidata
- Q27285820
- Wikipedia
- Lorlatinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Lorbrena is used for
LORBRENA ® is indicated for the 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. LORBRENA is a kinase inhibitor indicated for the 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. ( 1 , 2.1 )
How it works
12.1 Mechanism of Action Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. In mice subcutaneously implanted with tumors harboring EML4 fusions with either ALK variant 1 or ALK mutations, including the G1202R and I1171T mutations detected in tumors at the time of disease progression on ALK inhibitors, administration of lorlatinib resulted in antitumor activity. Lorlatinib also demonstrated anti-…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.