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Statement From FDA Commissioner on In Vitro Companion Diagnostics


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Scott Gottlieb, MD

Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products:

“With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling on diagnostic tests for oncology therapeutic products, where scientifically appropriate. [The] draft guidance notes that in some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group or class of therapeutic products, the companion diagnostic’s intended use should name the specific group or class of therapeutic products, rather than specific products.”

“The policy reflected in this guidance, when finalized, will make it easier for providers to use the same test in helping guide the use of a class of oncology therapeutic products, rather than one specific oncology therapeutic product within that class. The guidance will 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 in a class of molecularly targeted oncology therapeutic products to then extrapolate the use of that same approved or cleared diagnostic test to the entire oncology therapeutic product class.”

“We’re advancing this guidance to promote better patient care. We also recognize that there are commercial challenges for companion diagnostics. And so we’re trying to help sponsors more efficiently meet the requirements to support broader labeling. To advance these goals, 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.”

“As noted, that specificity in labeling can limit a potentially broader use of a companion diagnostic that may be scientifically appropriate. In some cases, there are multiple companion diagnostics approved or cleared by the FDA to detect the same mutations in the same specimen type. Similarly, in some cases, there are multiple FDA-approved therapeutics within a specific group or class of oncology therapeutic products…. The result is that, 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.”

“We’re concerned that the current situation is not optimal for patient care because a clinician may need to order a different companion diagnostic (ie, one that includes other therapeutic products on the label), obtain an additional biopsy from a patient, or both, to have additional treatment options. This is among the reasons why we’re looking to work with sponsors to pursue labeling a companion diagnostic to reference a specific group or class of oncology therapeutic products, when the evidence would support expanding the indication, for instance to “include a specific group or class of therapeutic products, rather than specific products.”

In oncology, precision medicine aims to match therapeutic products to those patients (and only those patients) who will positively respond to that therapeutic product, to maximize benefits and minimize risks from the therapeutic product received. Companion diagnostics inform both the development and the approved use of therapeutic products.”

“These products could enable greater flexibility for clinicians in choosing the most appropriate therapeutic product based on a patient’s biomarker status. It could also help advance better patient care.”

To view the full statement from Dr. Gottlieb, visit FDA.gov


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