Regulators on both sides of the Atlantic often have contradictory opinions about the same drug. Think Avandia, the GlaxoSmithKline diabetes drug withdrawn in Europe last year on the same day the FDA chose to severely restrict it, but keep it on the market. Or consider AstraZeneca's new blood thinner, which is approved in Europe but still in the queue at FDA.
Add Roche's Avastin to that list. After an emotional, sometimes hostile, two-day appeal hearing, the FDA's expert committee voted 6-0 in favor of pulling the drug's indication for breast cancer. Within 24 hours, European regulators announced that they were expanding Avastin's breast-cancer indication to include its use with a second chemo drug.
The FDA vote comes after two new studies of Avastin in breast cancer--required by the drug's provisional approval under the agency's fast-track program. The new data failed to confirm earlier research on the drug, finding instead the drug did not significantly prolong patients' lives. The studies also showed that Avastin only delayed cancer growth for up to three months on average, the agency said.
The FDA moved to pull the indication; Roche's Genentech unit appealed; and now the committee has voted. All that's left is for Commissioner Margaret Hamburg to make it official.
Rewind to December. At the same time FDA experts first moved to pull the breast cancer indication, the European Medicines Agency said Avastin could keep its metastatic breast cancer stamp of approval, but only in combination with the chemo drug paciltaxel. That's the drug that was used in the original study that led to Avastin's breast cancer nod. Use with the drugs in the two new trials--docetaxel and Roche's Xeloda (capecitabine)--were not approved, EMA said.
Now, however, EMA has decided to broaden the field. Avastin will be blessed for use with Xeloda, too. Xeloda was the companion drug in the Ribbon 1 trial, which showed that Avastin increased progression-free survival by 2.9 months over Xeloda alone. As NPR notes, the FDA called that difference a "small delay in tumor growth" that fell short of expectations based on earlier studies. Will EMA's differing interpretation pressure Hamburg to go against her committee?