"You can cut a couple of years out of the clinical trial process by basically doing your pivotal trial straight from Phase I," Richard Scheller, Genentech 's head of early stage research, tells Bill Berkrot and Ransdell Pierson. That's because Phase I is no longer limited to safety and dose. Now early-stage studies also frequently include the kind of proof-of-concept data that developers had waited to scout for in Phase II.

"What we're looking at many times is Phase I data where we're seeing levels of response that we haven't seen before in patients that have exhausted most of the therapies in a disease," said FDA's Dr. Richard Pazdur . And the chance of taking breakthrough drugs directly to patients with advanced, metastatic cases will likely make this field the biggest beneficiary of new regulations designed to fast-track preliminary approvals.

http://www.fiercebiotech.com/story/cancer-dru...e=internal