A new collaborative between the US Food and Drug Administration, National Cancer Institute (NCI), and Centers for Medicare and Medicaid Services will bring scientific rigor and validation to biomarker research, say the agencies. The Oncology Biomarker Qualification Initiative (OBQI; www.fda.gov/oc/mous/domestic/FDA-NCI-CMS.html) will be "a partnership between these three agencies to really for the first time collectively think about how we create the evidence base for biomarkers," says Anna Barker, deputy director of NCI.
The initiative, says Barker, seeks to identify which biomarkers are most relevant to cancer and have the strongest evidence base, and to conduct specific clinical trials to test those markers directly. For instance, how effective is the marker at predicting tumor recurrence, and how well does it reflect therapeutic response? First up is fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging of non-Hodgkin lymphoma (NHL) as an indicator of tumor progression.
Such studies "absolutely will affect how...
The initiative also has the potential to provide a clearer dialogue between the FDA and industry. "If I were looking to develop a drug for NHL, I would certainly be interested in knowing whether or not FDG-PET is going to be regarded by the FDA as an acceptable indicator for predictor of tumor response," says Barker. "That would give me a lot of comfort that this would be a pretty robust endpoint in terms of designing my trial."