USA – FDA Drafts Guidance on Oncology Companion Diagnostics

Developers of companion diagnostics were encouraged on Thursday to help guide the direction of newly drafted policies in support of broader labeling for a group or class of oncology therapeutic products.

“We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in announcing new draft guidance.

The 8-page draft guidance on companion diagnostics, which are in vitro diagnostic devices that provide information on the safe and effective use of its corresponding therapeutic product, introduces FDA’s support for developing companion diagnostics that allow for broader use among oncologists and their patients.

The agency recommends five considerations to developers seeking broader labeling, whether it be through the initial design or an application supplement. These relate to whether a specific group or class of oncology therapeutic products can be defined, there is enough clinical experience with at least two therapeutic products for the same biomarker-based indications, as well as whether there is a demonstrated analytical validity across a range of biomarkers and clinical validity in the intended disease area.

FDA also recommends developers consider whether there is “detailed understanding” of three factors to support broader companion diagnostic labeling in oncology. These include the mechanism of action of a group or class of oncology therapeutic products, the interaction between the therapeutic products and the companion diagnostic-detected biomarker(s) at the genetic mutation level…