1:11 PM
Dec 06, 2018
 |  BC Extra  |  Politics & Policy

FDA smoothing the path for class-wide cancer companion diagnostics

FDA Thursday announced the availability of draft guidance that is intended to make it easier for cancer companion diagnostics to be approved for a class of drugs, rather than only for a specific drug.

FDA Commissioner Scott Gottlieb discussed the draft guidance with BioCentury in November, saying it would give physicians more flexibility to prescribe drugs and reduce the likelihood of patients having to undergo multiple biopsies to determine whether specific drugs could be of benefit (see "FDA Planning Class-Wide Cancer Companion Diagnostic Guidance").

Gottlieb had told BioCentury the draft guidance could simplify treatment options for classes of targeted drugs such as EGFR and PD-1/PD-L1 inhibitors and could increase the market size for companion diagnostics.

In a statement Thursday, Gottlieb described benefits for individual patients of class labeling of companion diagnostics. “We’re concerned that the current situation is not optimal for patient care because a clinician may need to order a different companion diagnostic (i.e., one that includes other therapeutic products on the label), obtain an additional biopsy from a patient, or both, to have additional therapy treatment options.”

At least two public-private partnerships have been formed to develop class-wide approaches to companion diagnostics. The Blueprint PD-L1 Immunohistochemistry (IHC) Assay Comparison Project is harmonizing five PD-1 IHC assays that have been used in trials of different immunotherapies.

The Tumor Mutational Burden Harmonization Project, led by Friends of Cancer Research, is developing consistent methods for identifying patients who are likely to respond to immuno-oncology therapies.

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