The US FDA is exploring a potentially dramatic expansion of the accelerated approval mechanism. Under the concept, products showing a substantial, early effect on a clinical endpoint – as opposed a surrogate endpoint used for the existing accelerated approval process – could qualify for the new expedited pathway.
Commissioner Scott Gottlieb said Nov. 30 during a House Energy and Commerce Subcommittee on Health hearing that targeted therapies sometimes show early "outsized benefits," particularly in oncology.