Companion diagnostics: FDA finalizes guidance to broaden labeling for precision oncology

Regulatory NewsRegulatory News | 13 April 2020 |  By 

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at encouraging broader labeling for companion diagnostics used to guide precision oncology treatments and to facilitate their use with multiple drugs.
The nine-page guidance largely follows the recommendations made in the draft version released in late2018 and includes some clarifications and additional information from the previous version.
The guidance itself was developed to expand on FDA’s 2014 In Vitro Companion Diagnostic Devices guidance, which recommended companion diagnostic developers refer to a specific group of therapies in the labeling of their diagnostics rather than individual products when there is evidence to support the diagnostics’ uses across multiple products.
FDA defines specific groups of oncology products as ones with similar clinical experience and “the same approved indications, including molecular alteration(s), for which a companion diagnostic could potentially be labeled.”
To illustrate its recommendations, the guidance focuses on companion diagnostics used to identify patients with non-small cell lung cancer (NSCLC) with the two most common epidermal growth factor receptor (EGFR) mutations, exon 19 deletions and exon 21 (L858R) substitution mutations.
“In clinical practice, an oncologist generally considers the mutation profile of the tumor along with other factors when determining the treatment for a patient, such as the toxicity profile of the therapeutic product, the patient’s preference, and formulary options,” FDA writes, noting that narrow labeling for companion diagnostics can lead to clinicians ordering additional tests and biopsies to determine the course of treatment.
In the final guidance, FDA also explains that broader labeling for companion diagnostics will facilitate the clinical development and use of future oncology treatments.
To illustrate the issue, FDA includes a table listing five treatments indicated for NSCLC whose tumors have EGFR exon 19 deletions or exon 21 substitution mutations and the companion diagnostics indicated for use with each treatment. Among the four companion diagnostics listed, none are labeled for all five of the drugs, and one of the diagnostics is only labeled for one of the drugs.

FDA explains that “the clinical community would be better served” by tests labeled to identify patients whose tumors express specific molecular alterations for use with a specific group of drugs, in this case tyrosine kinase inhibitors.
However, FDA cautions that broadening labeling “is not as simple as just matching diagnostic targets with therapeutic targets,” and explains that differences between the diagnostics should be thoroughly evaluated to ensure their use across a group of products is clinically appropriate.


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