Living 4.2 months without bone metastases isn't worth a whole lot for patients with prostate cancer, according to a Food and Drug Administration advisory committee. The panel voted 12-1 recommending against approval of Amgen's
The lone vote recommending approval came from the patient representative. All the doctors thought the side effects didn't justify the benefit. Bone metastases are painful, but so is osteonecrosis of the jaw, a side effect seen in 5% of patients getting Xgeva.
The panel's vote is only a recommendation, but there's little chance of the FDA going against the outside experts when the vote is this lopsided.
For Amgen to get Xgeva's label expanded to an earlier indication, it will probably have to show that the earlier use extends survival. That would require a fairly long trial, and it might be difficult to run since Amgen isn't trying to get Xgeva to compete with other prostate cancer drugs such as Dendreon's
The fact that the doctors were so quick to dismiss not living with pain for four months is a bit of a bad sign for Exelixis
Looking for more high-tech stock ideas? Check out the Fool's free report, "3 Hidden Winners of the iPhone, iPad, and Android Revolution" where you'll find three companies quietly cashing in on the booming smartphone and tablet PC markets. Click here to get your free copy.