NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
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
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
Started Nov 2023
0Lung CancerNon-small Cell Lung Cancer
A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Started Aug 2023
56 enrolled
Non Small Cell Lung CancerMetastaticRecurrent
Loss of Exclusivity
LOE Date
Oct 4, 2038
153 months away
Patent Expiry
Oct 4, 2038
Exclusivity Expiry
Mar 3, 2028