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FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
One challenge FDA face right now, when it comes to developing diagnostics that can help target the delivery of cancer drugs, is the way these diagnostics are sometimes labeled. When an in vitro diagnostic test gets approved, it’s often based on the results of studies with one specific drug. As a consequence, the labeling of the test often reflects the use of that diagnostic in conjunction with just one drug. And, in turn, the drug can reflect the use of that medicine in conjunction with just one diagnostic test. This sometimes narrow labeling that ties a drug to a specific diagnostic test happens even in cases where the diagnostic test is applicable to all drugs in a specific class of cancer medicines. This is a challenge given the way cancer care is emerging. Increasingly, new drugs are targeting specific molecular markers that drive the growth and spread of cancer. Sometimes, multiple drugs in a class of medicines target the same marker in a largely similar fashion. In these