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mcbio

12/04/10 12:42 AM

#109950 RE: biomaven0 #109904

Me too. Even if the drug does not end up prolonging life, and even if the effect turns out not to be particularly durable, based on these early results I can't imagine they don't have an approvable drug.

(And it's not just prostate patients - several other common cancers have bone mets as one of their most troubling symptoms)
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I'm pretty sure during the R&D Day call that it was noted that XL184 is showing similar effects on bone mets in breast cancer patients, in particular, as it has with HRPC patients.

There was also the reference during the R&D Day call that improvement in bone mets by itself will likely not be an approvable endpoint. That improvement will have to be accompanied presumably either by some kind of survival benefit or by a significant pain benefit resulting from XL184 therapy (as has been shown so far). A caveat posted on here earlier is that if EXEL is going more for approvability based on pain benefit, there will be less room for error with side effects from XL184 as there would be if EXEL was aiming for approvability for XL184 based on survival benefit.
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zipjet

12/04/10 10:28 AM

#109960 RE: biomaven0 #109904

Right. Per the webcast some 300,000 people in the US have bone mets. That is about 4x the PC group.

ij