As Roche prepares for its Avastin hearing at the FDA, European regulators have decided to preserve the drug's breast cancer indication, but only in combination with the chemo drug paclitaxel. Pairing Avastin with another chemo drug, docetaxel, doesn't appear to help patients any more than docetaxel alone, EMA advisors said.
Roche was pleased with that decision, especially because it's facing the possibility that the FDA will nix the breast cancer indication altogether. "We are pleased that the European Commission is continuing to support Avastin in combination with paciltaxel," Roche CMO Hal Barron said in a statement. "This is important news for thousands of women living with incurable...breast cancer in the European Union."
The FDA's decision to pull Avastin's breast cancer indication has stirred up plenty of opposition, including some very vocal politicians in Washington. Despite support from a couple of key patient-advocacy groups and some cancer experts, the agency has had to tread carefully. That care will have to continue through Roche's appeal hearing in late June. Could the European approach be a way out for U.S. regulators?