Did FDA Make The Right Decision About Avastin?

Did FDA Make The Right Decision About Avastin?

November 21st, 2011 // 1:33 pm @

Now that the FDA has formally withdrawn the breast cancer indication for Avastin, still more debate is likely to break out. As you may recall, the agency acted after a handful of trials demonstrated the med was not safe and effective for this use, reversing a decision that was made as part of the controversial accelerated approval program.

In the year-long run-up to the decision, though, there was intense discussion over the basis for approval – progression-free survival instead of quality of life. At the same time, breast cancer patients and their allies clamored for the FDA to leave the indication intact. There were also rumblings that the agency was surreptitiously practicing a form of rationing was at work, since Avastin carries a price tag of about $80,000 a year, although the FDA denied this was the case (read here).

The FDA firmly cited clinical evidence as the rationale for its decision: “As noted, FDA may withdraw an accelerated approval when confirmatory trials fail to confirm clinical benefit, or when the evidence does not show that the drug is safe and effective. However, the agency also carefully considers the effect on current and future patients of such a decision, and there may be circumstances, in particular cases, that would lead the agency to conclude that it would be appropriate to exercise discretion and leave an approval in place pending further study. This is not such a case,” the agency writes in its decision.

“Accelerated approval was based on the results of E2100, which showed an effect on (progression-free survival) that would be large enough to constitute clinical benefit, despite the known risks of Avastin, which are serious. However, we now have five trials, and they have substantially changed our view of this drug. The current evidence no longer supports a determination that it has a strong effect in metastatic breast cancer, and it appears likely that its effects are very weak, while the risks associated with this drug remain serious and potentially life-threatening.”

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