FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

Regulatory NewsRegulatory News
| 19 February 2019 | By Ana Mulero 

Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products.

The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released last December. Some commenters showed support for the agency’s proposal to encourage class or specific-group labeling on CDx assays indicated for use with oncology therapeutic products, while others cautioned on unintended consequences.

AdvaMedDx, the diagnostics division of AdvaMed, said that it “strongly supports this goal and believes this draft guidance represents a positive step in advancing personalized medicine.” The group offered several recommendations to flesh out certain details, such as to address the use of real-world evidence (RWE) to support broader labeling. This recommendation was echoed by Foundation Medicine, the developer of the first FDA-approved comprehensive genomic profiling assay for all solid tumors that led to the finalization of a national coverage determination for next generation sequencing cancer panels.

Foundation Medicine, however, was also among those that expressed concerns with the unintended consequences relating to the impact on market competition, citing hindered innovation efforts. Another commenter with these concerns was AstraZeneca, which noted that “diagnostics manufacturers may be disincentivized to bring a new test to market if an existing test applies to full class.” Both companies also pointed to specific challenges associated with the premarket approval application submission process, including regulatory burden.

“As a CDx developer, it is unclear to FMI the level of evidence and burden of proof the Agency expects to be able to seek broad CDx labeling,” wrote Foundation Medicine vice president of regulatory affairs Christine Vietz. “Should the proposed guidelines be finalized, we recommend that the minimum criteria of clinical and analytical evidence required for consideration be explicitly defined.” 

Several commenters called for further clarification and examples of what would constitute a specific group or class of oncology therapeutic products for the purposes of implementing the agency’s proposed framework. These include biotechnology industry group BIO, Merck and Foundation Medicine. BIO also argued for drug and device sponsor considerations regarding issues specific to the co-development nature of CDx assays and oncology therapeutic products to be reflected in the guidance’s final version.

Yet another concern raised in submitted comments relates to lack of language in the draft guidance to emphasize that CDx labeled for use with one therapeutic product remain an acceptable option for drug sponsors and that specific-group or class labeling is not necessarily the expected or the only approach.



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