Late Friday, the FDA approved Genentech’s Avastin for breast cancer. The recommendation goes against the FDA’s own advisory panel – something they’ve been doing a lot of these days.
Yet, as Matt Perrone notes in his Associated Press article, this “could represent a shift in standards for assessing the effectiveness of cancer medicines.” The FDA based its assessment on tumor size and not on overall survival.
Some patient groups and agency watchdogs are complaining that it represents a lowering of standards and is a tacit approval of off-label usage, based on economics, not science.
Yet, I have to wonder if the Avastin indication was for prostate cancer, and not breast cancer, would we have seen a similar approval?
