Roche has wasted no time in appealing the FDA's choice to revoke Avastin's breast cancer indication. The company asked for another public hearing at the agency, during which it can make a last-ditch pitch in support of the drug, the Financial Times reports. Roche's request--which had been expected by FDA and industry observers--comes amid a loud public debate about the agency's decision.
If FDA grants the hearing, it would be the first of its kind, Bloomberg notes: "It's uncharted territory," Stefan Frings, Roche's Avastin franchise director, told the news service. "There's no company ever that has done this in the context of an accelerated approval."
Considering the rhetoric Avastin critics and supporters have exchanged since new data questioned the drug's efficacy in breast cancer, it's no surprise that the latest outcry has been heavily politicized. Republican opponents of healthcare reform used red-flag words like "rationing" in criticizing the agency's negative ruling--even though the FDA can't consider cost--and suggested that curtailing Avastin is just the wedge FDA needs to begin restricting drugs right and left.
Meanwhile, those who agree with FDA are touting a "triumph of science over politics," implying that the data makes an open-and-shut case for revoking the indication completely. But that's overstating things, obviously; otherwise, European regulators would have chosen to nix Avastin for breast cancer use rather than limiting it.
We've said it before, and we'll say it again: If biomarkers science were more advanced, this debate might be moot. One reason why breast cancer patients petitioned FDA on Avastin's behalf is because there's anecdotal evidence suggesting it does help some women. As the FDA noted during its briefing yesterday, new data identifying that subset of patients would change the calculus completely. Genentech has been trying to sort out those biological flags, but so far, no dice.
Other questions that have emerged: Should taxpayers and insurers pay more than $50,000 to improve a patient's quality of life for a short period of time? Should they pay for that expensive treatment for all women who qualify if only a very few will benefit? These are questions that don't have easy answers, given the skyrocketing cost of healthcare and the growing burden of Medicare spending. And they aren't the sort of things Americans enjoy discussing. But maybe this fight over Avastin will get some of those conversations rolling.