lorlatinib
lorlatinib: sourced relationships with 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 · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| PFIZER INC (PFE) Reported 2018-11-02 · Current development: unknownSource | Approved |
| PFIZER INC (PFE) Reported 2018-11-02 · Current development: unknownSource Carcinoma, Non-Small-Cell Lung | Phase 3 |
Clinical Trial Registry Records (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
Which companies have sourced relationships with lorlatinib?
lorlatinib has dated SEC/FDA relationship records for 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.