To develop therapeutics for oncology patients, wouldn’t it be better to incorporate biomarker research from the get-go? This is one of the thoughts behind the Oncology Biomarker Qualification Initiative, a collaboration between the Food and Drug Administration, National Cancer Institute, and the Centers for Medicare and Medicaid Services. These agencies will work with public and private institutions to understand how biomarkers, including genomic and proteomic markers, can be used to assess the impact of therapies and better match therapies to patients.
“When Herceptin was being developed, the company didn’t necessarily start off thinking how to identify patients who would actually respond to the drug,” says Wendy Sanhai, a senior scientific advisor at the FDA. It was at the insistence of the FDA, she says, that the company added the HER2 IHC diagnostic. Having a biomarker for a cancer therapeutic should be the rule rather than the exception, says Sanhai.
Through the recently announced initiative, collaborators will work together to address questions such as how particular biomarkers can be used to identify which cancer patients are at high risk of tumor recurrence; how to determine if a patient’s tumor is likely to respond to a specific treatment; and how to efficiently evaluate whether an investigational therapy is effective for tumor treatment. In the future, researchers envision being able to use biomarkers to assess, after one or two treatments, if a patient’s tumor is responding to treatment, or determine more definitively if a tumor is dying even if it’s not shrinking.
Validating biomarkers can help shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between the drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.
“Many potential biomarkers in the form of genes and proteins are beginning to provide clues about the presence of cancer or a precancer. Others, or even the same markers, are also informing us about the prognosis — the future course of an individual cancer,” says Dean Brenner, a biomarker researcher at the University of Michigan. “Such products are coming toward [the] market. We need a way to define what works and what does not work. [This] initiative recognizes the importance of development and validation of intermediate endpoints that might be used to predict more distant clinical endpoints.”
— Kate O’Rourke