FDA Drafts Guidance on Oncology Companion Diagnostics

Regulatory NewsRegulatory News | 07 December 2018 |  By 

The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling.

“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therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in announcing new draft guidance.

The 8-page draft guidance on companion diagnostics, which are in vitro diagnostic devices that provide information on the safe and effective use of a corresponding therapeutic product,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 of oncology therapeutic products can be defined, whether 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.

For broader labeling on previously approved or cleared companion diagnostics, developers are required to submit either a premarket application supplement or a new 510(k) submission. “Such submissions should generally include justification for use with a specific group or class of therapeutic products and valid scientific evidence under 21 CFR 860.7(c)(2) to support the broader labeling claims,” FDA said.

An example of a labeling issue in precision oncology involves the identification of epidermal growth factor receptor (EGFR) mutations in tumors of patients with non-small cell lung cancer as FDA-approved companion diagnostics that identify these mutations “are only indicated for a subset of the five FDA-approved therapeutic products,” according to the draft guidance. This is illustrated in the table below.


Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products: Draft guidance


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