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Lorlatinib Structure.svg
Clinical data
Routes of
Legal status
Legal status
  • experimental
CAS Number
Chemical and physical data
Formula C22H20FN5O2
Molar mass 405.43 g·mol−1
3D model (JSmol)

Lorlatinib (PF-6463922) is an experimental anti-neoplastic drug in development by Pfizer. It is a orally-administered small molecule inhibitor of ROS1 and ALK.

In 2015, FDA granted Pfizer orphan drug status for lorlatinib for the treatment of non-small cell lung cancer.[1]

Lorlatinib is able to cross the blood-brain barrier.[2]

Clinical studies[edit]

Several clinical trials are ongoing. A phase II trial comparing avelumab alone and in combination with lorlatinib or crizotinib for non-small cell lung cancer is expected to be complete in late 2017. A phase II trial comparing lorlatinib with crizotinib is expected to be complete in mid-2018.[3] A phase II trial for treatment of ALK-positive or ROS1-positive non-small cell lung cancer with CNA metastases is not expected to be complete until 2023.[4] Preclinical studies are investigating lorlatinib for treatment of neuroblastoma.

In 2017, Pfizer announced that lorlatinib was shown to have activitiy against lung and brain tumors in people with ALK or ROS1 positive advanced non–small cell lung cancer.[5]