NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
32
Data completeness
7/8 — Comprehensive
Priority Review
LORBRENA (lorlatinib) by Pfizer is kinase inhibitors [moa]. First approved in 2018.
Drug data last refreshed 35m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lorlatinib (LORBRENA) is an oral small-molecule kinase inhibitor approved by the FDA in November 2018. It is indicated for patients with ALK-positive or ROS1-positive non-small cell lung cancer, working by potently inhibiting receptor tyrosine kinases to block tumor progression. The drug represents a key treatment option for genetically defined lung cancer populations.
$76MPart D
Peak12.0 years to LOEThe product is at peak commercial maturity with modest Part D spending of $76M in 2023, suggesting a stable but niche indication with limited team expansion opportunities.
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 (32)
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Started Oct 2026
30 enrolled
Lung Cancer
Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC
Started Aug 2026
160 enrolled
Non-Small Cell Lung Cancer (NSCLC)HyperlipidemiaALK Gene Mutation+1 more
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
Started Jul 2026
80 enrolled
ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib
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
Worked on LORBRENA at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.