Does Avastin nod lower approvals bar?

More proof that fortune-telling is a dicey business: The FDA Friday approved Avastin for use against breast cancer, going against the recommendation of its own advisory panel and confounding experts who had been predicting that the agency would at the least ask for more data.

Perhaps, however, the FDA got some of that additional data in the days leading up to Friday's meeting. Genentech had, you'll recall, passed along the results of a new study shoring up Avastin's efficacy against the disease. Genentech told the San Francisco Chronicle that, since the advisory panel voted 5-4 against approval, it had been working closely with the FDA to address its concerns (otherwise known as lobbying). And it did ask for more data, just not the way observers had predicted. The new conditional approval comes with a demand for additional studies over the next several years; if that research turns up new safety concerns or efficacy problems, then the approval could be yanked.

Some see the decision as a sea change. In this view, the FDA has now lowered the bar for other cancer-drug approvals. That's because Avastin proved effective at stopping tumor growth but not at extending survival time, which has long been the gold standard for cancer treatments. If Avastin got an OK based on disease progression, so might many other cancer hopefuls waiting in the wings. Or so the theory goes. As we say, fortunetelling can be a dicey business.

- check out Genentech's release
- see the brief in the Washington Post
- read the San Francisco Chronicle report

Related Articles:
Genentech awaits Avastin decision. Report
Genentech faces crucial Avastin decision. Report
Will FDA care about new Avastin study? Report
FDA: Avastin lackluster in breast cancer. Report

Suggested Articles

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.

Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients.