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DewDiligence

08/24/11 11:43 AM

#125588 RE: biomaven0 #125585

AMGN has presented data in this patient population on time to first SRE and the rate of (first and subsequent) SREs for patients on Xgeva and Zometa (#msg-46426917).
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NP1986

08/24/11 12:32 PM

#125594 RE: biomaven0 #125585

Mitoxantrone was approved several years ago. If you look at recent approvals like Jevtana and Zytiga, overall survival was the endpoint used. The FDA might still be okay with pain scores as part of the main endpoint.

I don't know if cabozantinib will be able to pass for a supportive care medication like samarium (or even Zometa or Xgeva for that matter) due to its safety and tolerability profile, which is why I think the FDA will want to see survival data.

I don't see EXEL being in a position to advance cabozantinib on its own for a prostate cancer indication.