FDA's new breakthrough therapy pathway promises to get truly exceptional new therapies to patients faster, but key players in academia and Europe will need to get on board, and potential manufacturing roadblocks will need to be solved, according to senior agency officials and patient advocacy groups.

The breakthrough therapy pathway was first proposed at a 2011 Friends of Cancer Research/Brookings Institution meeting and was enacted this year as part of the FDA Safety and Innovation Act (FDASIA) that reauthorized prescription drug user fees.