Call it an Avastin side effect. The brouhaha over the Roche drug's breast cancer indication has cast a spotlight on the FDA's fast-track approval program--namely, the follow-up studies drugmakers are required to perform to further prove that their treatments work. The problem? Companies aren't following through on the follow-up.
FDA officials want to know why. At an advisory committee meeting, the FDA and its outside experts grilled GlaxoSmithKline, Eli Lilly, Amgen and others about their failure to complete the required studies. "These confirmatory trials are as important--if not more important--than the initial trials leading to the accelerated approval," FDA cancer chief Richard Pazdur said (as quoted by the Wall Street Journal). Some companies have taken more than six years to complete the trials.
The companies offered a defense; it can be tough to recruit patients for these follow-up trials. But some of the trials can't go forward because by the time drugmakers got around to doing them, the protocols had grown outdated. As for the companies mentioned above, GSK had recruitment trouble with its Bexxar blood cancer drug; Lilly says an Erbitux study is forthcoming--it hopes this year; Amgen said it had met its commitments.
What incentive do they have to wrap the studies up? Obviously, if some of these studies are seven years in the making, the FDA isn't doing much to whip them along. And just think of the most recent example: Roche did perform those studies, and the less-than-impressive results led the FDA to yank Avastin's indication for breast cancer. When AstraZeneca turned in follow-up data on Iressa in 2005, the FDA pulled that approval as well (the drug has gained new life from genetic screening, however). The agency says that, given the nature of the program, at least some drugs will fail.
As the WSJ points out, Europe's accelerated program grants conditional approval for just one year, renewable only if the drugmakers are making progress toward meeting their follow-up promises. Padzur proposes discussing the follow-ups every year at a meeting like this one, presumably to remind companies of their obligations.
- read the WSJ piece