Another step forward for personalized medicine

By September 8, 2011Pharma Beat

The FDA just approved Xalkori (crizotinib) to treat the small percentage of patients with late-stage non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. The drug was approved alongside its companion diagnostic test (the Vysis ALK Break Apart FISH Probe Kit) which can help identify the one to seven percent of patients with NSCLC who have the ALK gene abnormality. By selecting patients who are more likely to respond to the drug, the hope is to maximize efficacy while minimizing side effects. The FDA encourages the co-development of pharmaceuticals along with an appropriate diagnostic, and Xalkori represents the second targeted therapy with a diagnostic test approved in 2011. For more information, please go to