The recent problems involving Avastin — in which FDA decided to yank its approval for the drug to be used as a treatment for metastatic breast cancer — shows the importance of carrying out follow-up studies for cancer treatments, says In the Pipeline's Derek Lowe. Now, it seems some companies are skipping that step, which, Lowe adds, "isn't good." Conditional approval is granted by FDA as a way to get a needed drug to patients while waiting for more data. But some companies are slowing down the follow-ups either because they're having trouble rounding up enough patients for the trials or because they're worried about the results. "Opinions are all over the place on how lenient the FDA's approval process really is," Lowe says. "You have people who say that the agency is dragging its feet on life-saving treatments, and people (looking at the same data set) who say that they're letting too much stuff through on the flimsiest grounds." But no matter what side of the argument you're on, he adds, everyone can agree that "we're going to require evidence at some point."
Skipping a Step
Feb 24, 2011