lorlatinib
lorlatinib: developed by 1 company · 8 clinical trials tracked · 1 FDA decision.
lorlatinib evidence translation
What we can confirm
1 FDA record · 8 tracked trials
What it means
What to watch
Prepared research question
How could lorlatinib → PFE affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 2 study sponsors
Related indications
Development Pipeline (2)
| Company | Phase |
|---|---|
| PFIZER INC (PFE) | Approved |
| PFIZER INC (PFE) Carcinoma, Non-Small-Cell Lung | Phase 3 |
Clinical Trials (8)
A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer
Primary endpoint: Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion
Primary endpoint: Disease Control Rate
A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS
Primary endpoint: real-world progression-free survival
A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers
Primary endpoint: Maximum tolerated dose (MTD) (Phase I)
A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib Monotherapy in Crizotinib and Platinum-based Chemotherapy Treated Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer Subjects in China
Primary endpoint: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment
A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)
Primary endpoint: Objective Response Rate
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
Primary endpoint: Event free survival (EFS) (Arm A, B, D, and E)
A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile
Primary endpoint: Percentage of patients that are treated based on their molecular tumor profile
FDA Decisions1 records
Frequently asked questions
Who is developing lorlatinib?
lorlatinib is being developed by PFIZER INC.
How many clinical trials involve lorlatinib?
BioSniper tracks 8 clinical trials involving lorlatinib.
What is lorlatinib's latest FDA decision?
The most recent tracked FDA decision for lorlatinib is Approval for 1 INDICATIONS AND USAGE 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 ), dated November 2, 2018.