Xgeva Comes Up Short On Clinical Benefit, Has Too Much Risk, ODAC Tells FDA
By
Cathy Dombrowski / Email the Author / “The Pink Sheet” DAILY Feb. 8, 2012
Word Count: 657 / Article # 14120208006
Executive Summary
The oncologic drugs panel rejects an expanded indication for Amgen’s denosumab, saying a 4.2-month delay in progression of bone metastasis in castrate-resistant prostate cancer patients does not offset the risk of osteonecrosis of the jaw.
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