Genentech scored a huge regulatory victory recently when the FDA approved its cancer drug Avastin as a treatment for breast cancer. The approval came as a surprise: An agency advisory committee had recommended against approval back in December.
There’s no denying this is big for Genentech, whose stock has declined over the last couple of years as its once red-hot growth has cooled. Avastin is already the company’s biggest seller; previously approved for colorectal and lung cancers, the drug brought in more than $2 billion in revenue in 2007. And adding breast cancer to the mix means another billion dollars a year. The approval is also validation of the common strategy of label expansion, in which drug companies try to get the most bang for their development buck by widening the number of diseases for which a single drug can be prescribed.
The question remains, however, whether the approval is as good for cancer patients as it is for Genentech. The FDA’s advisory panel had recommended against approval because clinical studies had shown that, while the drug slowed the progress of breast cancer (what’s referred to as “progression-free survival”), it didn’t actually lengthen patients’ lives (called “overall survival”).
The latter statistic has historically been the standard for FDA approval of cancer drugs. The Avastin approval is thus widely seen as a lowering of the regulatory bar.
There’s something to be said for easing up on drug approvals, of course.
Some patient advocates and investors have complained about the FDA’s recent aversion to risk. Getting a good sense of overall survival rates takes a long time, and in the meantime, there are women who might benefit from Avastin. (Thousands of breast cancer patients already take the drug “off-label” anyway, but insurance coverage for that kind of use is extremely limited. FDA approval makes it much more likely to get coverage.)
The Wall Street Journal made the moral case for FDA approval on Thursday, arguing that privileging overall survival over progression-free survival is an archaic standard and that the FDA shouldn’t withhold potentially helpful treatments from patients. Conversely, Niko Karvounis at Health Beat argues that the approval of Avastin encourages mediocrity in drug development: If companies can continue to milk existing drugs based on unimpressive trial data, they’ll keep putting their money into label expansion rather than looking for truly innovative treatments. Besides, Karvounis says, progression-free doesn’t necessarily equal symptom-free, especially since Avastin produces some pretty nasty side effects.
It’s quite the moral quandary. But here’s one potential parallel to consider: The FDA approved Vytorin based on data showing it lowered cholesterol. But now it seems that Vytorin’s cholesterol-lowering abilities had no effect in reducing heart attacks — which is, after all, the whole point. Seems to me there’s a similar distinction to be made between progression-free survival and overall survival: If Avastin isn’t helping people live longer, what’s the point?
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