publication date: Oct. 13, 2017

FDA: the development of site-agnostic indications calls for development of sponsor-agnostic diagnostics

By Paul Goldberg

Earlier this year, when FDA approved Merck’s PD-1 inhibitor Keytruda (pembrolizumab) for “site-agnostic” indications, it raised new questions that will likely shape the future of oncology:

In indications that are defined by biomarkers, will diagnostics in effect create a bundle containing the drug and the assay, driving the patients to a particular drug? Or will these diagnostics allow patients to be tested for a range of therapies?

In other words, is it possible to develop companion diagnostics in manner that is “sponsor-agnostic”?

This cluster of fundamental technological and policy questions is just starting to be formulated as the field adjusts to the future where indications may be defined by molecular characteristics of agents, as opposed to tumor sites.

Earlier this week, a group of top oncology officials at FDA published a “perspective” piece in the New England Journal of Medicine, in which they laid out the agency’s concerns about a future where companion diagnostics are tied to specific drugs:

“Although sponsors have conventionally focused on the development of a drug, the strategy of pursuing site-agnostic indications must focus on both drug and biomarker development. For a biomarker-defined indication, multiple drugs may be developed by various commercial sponsors. The establishment of some new disease-indication–defining biomarkers (e.g., tumor mutation burden as a predictor of response to immunotherapy) may require a more collaborative approach than conventional drug development. If a biomarker will, in essence, define the disease indication, then it should be developed through the collaboration of multiple stakeholders including commercial sponsors, device manufacturers, academia, and patients.”

Continue reading FDA: the development of site-agnostic indications calls for development of sponsor-agnostic diagnostics

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