The US Food and Drug Administration granted accelerated approval to Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on (Xalkori (crizotinib) and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on Alcensa (alectinib) or Zykadia (ceritinib) as the first ALK inhibitor therapy for metastatic disease.

Lung cancer is the leading cause of cancer death in the US and around the world, highlighting the importance of developing effective new approaches to treatment.

Up to 7% of NSCLC patients have an abnormal version of the ALK gene. Lung cancers with this abnormality typically occur in non-smokers. The abnormal gene contributes to the growth and development of cancer cells however several precision cancer medicines have been approved over the last few years that target ALK kinase and improve the treatment of individuals with ALK + NSCLC.

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About Lorbrena

Lorbrena is a third-generation oral medication that blocks the protein produced by the abnormal ALK gene, which is determined by testing a sample of tumor tissue.

The approval of Lorbrena was based on a subgroup of 215 patients with ALK-positive metastatic NSCLC who were previously treated with one or more ALK kinase inhibitors. The overall response rate to Lorbrena treatment was 48%, with 4% complete and 44% partial responses. The estimated median response duration was 12.5 months.

In addition, a 60% response rate was reported among patients with measurable intracranial lesions and the median duration of response in these patients was 19.5 months.

Reference: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm625027.htm

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