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
- 2018-11-02: 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)
History of changes in EMA indication
- 2019-05-06: Initial conditional approval as Lorviqua
History of changes in Health Canada indication
- 2019-02-22: Initial notice of compliance with conditions
- 2022-05-20: Conditions were met
History of changes in PMDA indication
- 2018-09-21: Conditional new approval for the treatment of unresectable or recurrent anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitors.
- 2021-11-25: New indication for the treatment of unresectable or advanced/recurrent anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer.
Patient Drug Information
Also known as
- Code name: PF-06463922
- Brand name: Lorbrena, Lorviqua