Study Finds Drug Labels Lack Evidence for Pharmacogenomic Testing

Despite the continued drive toward companion diagnostic development, as witnessed by the increasing number of diagnostic-pharmaceutical company partnerships, new research raises doubts as to whether biomarker testing recommendations are ready to be included in drug labels, given a lack of associated clinical utility data. “Our analysis revealed deficiencies in the evidence provided in drug labels that supports the use of many pharmacogenomics biomarkers,” write the authors of an Oct. 13 JAMA Internal Medicine study. “It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.” Biomarkers are increasingly being relied upon to predict a drug’s efficacy and the likelihood of toxicity in individual patients. But the researchers say that while more than half of drug labels make clinical recommendations based on biomarker test results, less than one-sixth of drug labels contained or referenced convincing evidence of the clinical utility of biomarker testing. The researchers utilized publicly available U.S. Food and Drug Administration  databases to evaluate the evidence supporting pharmacogenomic biomarker testing in drug labels (both clinical validity and clinical utility). They examined the first available drug label that contained mention of a drug’s associated biomarker. The researchers […]