Ashlee - an FDA fast track can take as few as three months and as long as a full year, depending on how fast the company gets all of the study paperwork in to the FDA, and how grave the need, and how quickly the company can ramp up into full-scale production earlier than planned. Don't underestimate that last one - if it became generally available tomorrow, they'd need to potentially be able to supply the drug to thousands of refractory stage IV patients. That's a heckuva lot more drug to manufacture than would be used by 750 study participants - and after manufacture, it would have to be purified, assayed, and put into safe packaging (and the FDA has to approve the packaging and label content, too.)
When BMS got Videx fast-tracked...similar situation, people on the Videx arm of the Phase III study did so well that the trial was ended earlier and the drug was compassionately released to all participants in the study...BMS already had a lot of its ducks in a row on the reporting and packaging end. They'd been scaling up production for a few months so that they could be ready. Videx (didanosine) was, at the time, the ONLY alternative to AZT that was available. The need (especially in Africa and Haiti) was dramatically grave because Videx was oral, and AZT had to be given by IV. So, within three months, not only could the control study participants have the drug, but the World Health Organization agreed that it was ok for BMS to distribute them as needed in countries where the need was greatest.
HOWEVER - here in the states, even though Videx had fast-track FDA approval, it did take some time (I don't remember exactly, but at least six months) for the insurance companies to move Videx from the "experimental" list of drugs and begin to regularly approve it...and then, only for patients for whom AZT had failed. So someone whose T cells were hanging in there on AZT couldn't get Videx in the beginning, and for several months after it was considered "approved." They could get it on compassionate release from the BMS program, but without that program, they wouldn't have been able to afford the drug because insurance wouldn't cover it.
And I gotta tell you, when BMS got that fast track approval, and was finally able to ship US docs the first bottles of Videx, we had the biggest damn party you have ever seen. I couldn't even estimate how many hours I spent in haz-mat style gown up testing that drug. The overtime I put in on that drug and Taxol is the reason my condo is paid off. It was YEARS of work to get both of those drugs to fast-track status. Fast-track status for a drug is the equivalent of the "overnight success" of a performer who has been working his/her tail off in dive bars for a decade.
With regorafenib, the first patients who will be eligible to get it may have to fight for approval of the drug with their insurance companies, AND the only patients eligible for it will be those people whose cancer has progressed on all other drug regimens.
Supposedly, the report is supposed to be in to the FDA by the end of the year. They have either 30 or 45 days to act on the fast-track approval status of the drug. Meanwhile, the pharmaceutical company has to ramp up production, have that production FDA-inspected, design packaging and a label that the FDA approves, and get prepped to produce and distribute the drug. And delays by either party at any point along the way mean it will take longer to get the drug into the hands of docs who can prescribe it to patients.
I want it approved, too...but the reality of the process tells me mid-year, 2012, and then probably only for completely refractory (chemo resistant) patients who have no other options...and those patients will likely have to go hand to hand with their insurance companies to get the drug covered if they're approved to receive it.
Don't get me wrong - I'm over the moon when progress is made with new drugs and treatments. But over 20 years in pre-clinical drug testing has reinforced that the process of getting that new drugs into full distribution is NOT an instant gratification kinda thing.