Does Avastin deserve another look from regulators? Avastin lost its FDA approval for late-stage breast cancer last year after a contentious review, but now two new studies show that it might help women in the early stages of the disease. Both tested Avastin as an add-on to chemo for breast tumors that hadn't spread, and both found that the Avastin patients were more likely to have their cancers disappear.
However, drilling deeper pulls up a few questions. The first study, undertaken in Europe, found that women with "triple-negative" breast cancer--a form of the disease that's aggressive and difficult to treat--responded most strongly to the addition of Avastin. The second study, performed in the U.S., found that women with the triple-negative disease did benefit from Avastin, but patients with hormone-receptor-positive cancer responded best.
As the Los Angeles Times points out, back when the drug's breast-cancer approval was revoked, experts warned that Avastin would likely be found to benefit certain subgroups of patients. Indeed, with that prospect in mind, Roche ($RHHBY) has been digging into the data and testing potential biomarkers that might help identify patients who benefit most from the drug.
The new studies support that subgroups-do-benefit view. But the data isn't cut-and-dried, an American Cancer Society expert told ABC News. "I still don't believe there's a clear message from these studies as to who would benefit and how the medication should be used," deputy chief medical officer Len Lichtenfeld said. And one breast-cancer expert told ABC that worries about side effects remain.
So, should the FDA step back into the Avastin fray? It probably won't do so voluntarily, and Roche certainly has plenty of incentive to submit new data if it's warranted. For now, it looks as if Roche agrees with the folks who decline to draw big conclusions from the latest studies. The new data are "interesting and important," Roche told Bloomberg. "Longer follow-up from these studies is needed before definitive conclusions can be drawn."
In the meantime, perhaps Roche can place its Avastin hopes within its strategy for the company itself: Diagnostics. As Lichtenfeld says, "Frankly, what would help in further understanding Avastin are predictive tests on what type of women would benefit." No doubt the company would agree.