NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
29
Data completeness
6/8 — Strong
Priority Review
LORBRENA (lorlatinib) by Pfizer is kinase inhibitors [moa]. First approved in 2018.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LORBRENA (lorlatinib) is an oral small-molecule kinase inhibitor approved by the FDA in November 2018 for the treatment of ALK-positive non-small-cell lung cancer. It works by inhibiting anaplastic lymphoma kinase (ALK) and other related kinases, blocking cancer cell proliferation. The drug is indicated for patients with ALK-positive NSCLC, including those with brain metastases and resistance to prior ALK inhibitor therapy.
$76MPart D
PeakStable
12.3 years to LOEThe product is at peak maturity with moderate Part D utilization ($76M annually, 3,791 claims in 2023), indicating a stable commercial base supporting ongoing brand and medical affairs teams.
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (29)
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC
Started May 2026
50 enrolled
Non-Small Cell Lung Cancer ALK-positive
A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment
Started May 2026
200 enrolled
Non-Small-Cell LungALK-positive Advanced NSCLCALK-positive Non-small-cell Lung Cancer+1 more
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
Started Aug 2025
15 enrolled
High Grade GliomaDiffuse Intrinsic Pontine GliomaAnaplastic Astrocytoma+6 more
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.
Started Jul 2025
35 enrolled
Carcinoma, Non-Small-Cell Lung
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
Started Jan 2025
90 enrolled
ALK+ Non-Small-Cell Lung Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.