Lorlatinib

Lorlatinib (PF-6463922), sold under the brand name Lorbrena in the United States, Canada, and Japan, and Lorviqua in the European Union, is an anti-neoplastic drug developed by Pfizer. It is an orally-administered small molecule inhibitor of ROS1 and ALK. Lorlatinib (PF-6463922), sold under the brand name Lorbrena in the United States, Canada, and Japan, and Lorviqua in the European Union, is an anti-neoplastic drug developed by Pfizer. It is an 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 (NSCLC). Lorlatinib is able to cross the blood-brain barrier. 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.A phase II trial for treatment of ALK-positive or ROS1-positive non-small cell lung cancer with CNS metastases is not expected to be complete until 2023.Preclinical studies are investigating lorlatinib for treatment of neuroblastoma. In 2017, Pfizer announced that lorlatinib was shown to have activity against lung and brain tumors in people with ALK or ROS1 positive advanced non–small cell lung cancer. In 2018, the FDA approved lortalinib for second or third line treatment of ALK-positive metastatic non-small cell lung cancer. In February 2019, the European CHMP of EMA recommended the granting of a conditional marketing authorisation for lorlatinib. In May 2019 the European Commission approved lorlatinib for the 28 countries of the EU.