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FDA Thursday announced the availability of draft guidance that is intended to make it easier for cancer companion diagnostics to be approved for a class of drugs, rather than only for a specific drug.

FDA Commissioner Scott Gottlieb discussed the draft guidance with BioCentury in November, saying it would give physicians more flexibility to prescribe drugs and reduce the likelihood of patients having to undergo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"). ...