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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Biologics Evaluation and ResearchOncology Center of Excellence
This guidance describes considerations for the development and labeling ofin vitro companion 17 diagnostic devices ( referred to as “companion diagnostics” herein) to support the indicated uses 18 of multiple drug or biological oncology products, when appropriate. This guidance expands on 19 existing policy, surrounding broader labeling (i.e., labeling that is expanded), which notes that in 20 some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for 21 use with a specific group or class of therapeutic products, the companion diagnostic’s intended 22 use/indications for use should name the specific group or class of therapeutic products, rather 23 than specific products. The specific group or class of oncology therapeutic products would be 24 identified for this purpose based on sufficient and consistent clinical experience with the 25 therapeutics with the same approved indications, including mutation(s) and disease, for which a 26 companion diagnostic could potentially be labeled (as discussed in this document). To describe 27 FDA’s current thinking on this topic, the guidance discusses a specific example, companion 28 diagnostics that identify patients with non-small cell lung cancer (NSCLC) whose tumors have 29 the most common epidermal growth factor receptor (EGFR) mutations, exon 19 deletions or 30 exon 21 (L858R) substitution mutations.
For questions regarding this draft document, contact (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; (CDRH) Reena Philip at 301-796-6179; or (CDER) Julie Schneider 240-402-4658.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2018-D-3380.