FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury.
Class-wide labeling 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, Gottlieb said.
FDA plans to allow companion diagnostic developers to submit data that would support approval for a class or group of cancer drugs, or to broaden an existing approval from a specific drug to a class or group.
Gottlieb said the guidance is aimed at simplifying treatment options for classes of targeted drugs, like EGFR inhibitors and PD-1/PD-L1 inhibitors.
The guidance could make the development of companion diagnostics more commercially attractive by increasing market size, he said.
FDA’s approach could also facilitate public-private initiatives to validate broader use of companion diagnostics that were created for specific drugs.
For example, the Blueprint PD-L1 Immunohistochemistry (IHC) Assay Comparison Project is a collaboration between academic and professional groups and biopharma companies to harmonize five PD-1 IHC assays that have been used in trials of different immunotherapies.
Friends of Cancer Research is leading the public-private Tumor Mutational Burden Harmonization Project that is developing consistent methods for identifying patients who are likely to respond to immuno-oncology therapies.