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FDA Issues Draft Guidance to Address Challenges With CDx Oncology-Class Labeling

NEW YORK (GenomeWeb) – The US Food and Drug Administration today issued a draft guidance document that aims to make it easier to get oncology-class labeling on companion diagnostic tests for therapeutic products.

Broadly, the initiative aims to address labeling challenges associated with developing companion diagnostics that can help target the delivery of cancer drugs, FDA Commissioner Scott Gottlieb said in a statement.

More specifically, the draft guidance addresses cases in which there's enough evidence to conclude that the CDx is appropriate for use with a specific group or class of therapeutic products. In those cases, the CDx's intended use should name the specific group or class of therapeutic products rather than specific products, Gottlieb said.

He said that the proposed guidance will describe considerations for the development and labeling of in vitro companion diagnostic devices to support the indicated uses of multiple oncology therapeutic products.

The guidance would help guide test developers who could use the data generated from the study of an approved or cleared diagnostic test that's evaluated in relation to just one oncology therapeutic product within a class of molecularly-targeted oncology therapeutic products. The test developers would be able to use the study data to extrapolate the use of that same approved or cleared diagnostic test to the associated oncology therapeutic product class.

The FDA frequently approves an in vitro diagnostic test based on the results of studies conducted with one specific drug. The labeling of the test often reflects the use of that diagnostic in conjunction with just one drug. Further, 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, Gottlieb noted.

In some cases, the FDA clears or approves multiple companion diagnostics to detect the same mutations in the same specimen type. Similarly, in some cases, the agency approves multiple therapeutics, such as drugs that are approved for use in the same indications, including the same mutations and the same disease, and are within a specific group or class of oncology therapeutics.

In some cases, not all of the oncology therapeutic products in a specific group or class are being included on all of the labels of approved or cleared companion diagnostics to detect mutations that define the specific group or class, the FDA said.

"We're concerned that the current situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, [such as] one that includes other therapeutic products on the label, obtain an additional biopsy from a patient, or both, to have additional therapy treatment options,” Gottlieb said.

The new guidance is part of recent broader efforts by the FDA to advance tools that help personalize care for patients.

The FDA is accepting comments on the new CDx draft guidance for 60 days following its publication in the Federal Register.