Unfortunately, the decision from the Food and Drug Administration, which is expected tomorrow, doesn't look too promising. The FDA advisory panel voted 12-1 against recommending expanding the use of Xgeva into patients whose tumors haven't expanded beyond the primary site.
Xgeva actually passed its clinical trial testing the drug in these earlier patients, but the committee of outside experts didn't think the 4.2-month delay in the onset of bone metastasis justified the side effects.
I can't even see how this binary event is worth buying as a lottery ticket. The FDA sometimes throws out positive recommendations and rejects a drug, but an approval overruling a negative recommendation with such broad a margin would be unprecedented.
Even though tomorrow's letter from the FDA will likely be a rejection, it won't be useless. The agency should lay out what Amgen needs to do if it wants to get Xgeva approved for use in patients earlier in the prostate cancer progression. Exelixis'
If that's what it'll take to get Xgeva approved in an earlier setting, Amgen will have an uphill battle. Delaying the onset of metastasis by more than four months should translate into some benefit, but it might be too small to demonstrate in a reasonably sized trial. Dendreon's
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