Richard Pazdur, oncology chief at FDA, says he plans to push the breakthrough drug program hard. He says the staff at FDA view this as a potentially game changing mechnism to get new therapies on the market and change lives -- provided the drugs show their stuff early in clinical programs.
Pazdur says he is prepared to make this a priority in his division and the FDA will partner with companies with breakthrough status to conference early and often to help shepard drugs through the agency. This could shave a couple years off a program's reaching the market. The agency will even work to adapt trials as information becomes available.
Industry observers are cautiously optimistic. But, like everything FDA (or government for that matter), the proof is in the actual performance. Right now, companies like Merck, Roche and BMS have oncology drugs with this designation. We'll see how they progress to the market or not. See Fierce Biotech.
Posted by Bruce Lehr June 3rd 2013.