Class/mechanism, from the NCI Drug Dictionary: An orally available, ATP-competitive inhibitor of the receptor tyrosine kinases, anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (Ros1), with potential antineoplastic activity. Upon administration, lorlatinib binds to and inhibits both ALK and ROS1 kinases. The kinase inhibition leads to disruption of ALK- and ROS1-mediated signaling and eventually inhibits tumor cell growth in ALK- and ROS1-overexpressing tumor cells. In addition, lorlatinib is able to cross the blood brain barrier.
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Diseases for which it is used
History of changes in FDA indication
- 11/2/2018: Granted accelerated approval for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. (Based on B7461001)
- 3/3/2021: Granted regular approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. (Converted to regular approval; prior therapy requirement removed; based on CROWN)
Patient Drug Information
Also known as
- Code name: PF-06463922
- Brand name: Lorbrena