Quality Of Biomarkers Questioned Again; Lancet Report Calls For Better Evidence
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAs personalized medicine shifts from theory to practice, concerns are mounting about whether the evidence behind many biomarkers is sufficient to make pharmacogenomic testing worthwhile – suggesting sponsors should pay careful attention to providing evidence to support use of companion diagnostics.
You may also be interested in...
With the development of targeted therapies and companion diagnostics increasing, AmerisourceBergen Consulting’s president advises pharma industry to bring payers in around Phase II to ensure trials give them data they need to cover drugs and diagnostics.
Erbitux wins FDA approval for first-line metastatic colorectal cancer negative for KRAS mutations detected with a companion diagnostic specifically approved for the drug. In theory, earlier use could help shore up sales. But the drug faces a tough competitor in the dominant Avastin and new products are on the near horizon.
Though the tracks and sessions are still named largely for organs and other phenotypic descriptions of cancer, the notion of basing treatments on the molecular drivers of a tumor alone is pervasive at this year’s meeting of the American Society of Clinical Oncology, June 1-5 in Chicago.