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
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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson, Dendreon, and Exelixis. Motley Fool newsletter services have recommended buying shares of Exelixis and Johnson & Johnson. Motley Fool newsletter services have recommended creating a diagonal call position in Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.