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

To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2018 The Cancer Letter Inc.