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Exelixis Falls on FDA Prostate Cancer Trial Design Setback

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On Monday's conference call, Exelixis CEO Morrissey said initial feedback received from FDA in August suggested the agency was willing to grant an SPA for the pain relief trial. However, the FDA changed its tune in follow-up comments sent to the company in October.

Patients enrolled in the cabozantinib studies will have advanced, metastatic prostate cancer that no longer responds to the standard chemo regimen of Taxotere and J&J's Zytiga. These are very sick prostate cancer patients with significant prostate cancer-related pain who have few or no treatment options left.

The first study with a pain relief endpoint will begin before the end of the year. The second study, with an overall survival endpoint, will begin in the first half of next year.

--Written by Adam Feuerstein in Boston.



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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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