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Amgen’s Prolia Gets Priority Review for Bone Cancer Indication
The FDA has granted Amgen’s bone-building drug Prolia a priority review for treatment of bone cancer, giving the drug a Nov. 18 user fee action goal date. The indication would be the second for Prolia (denosumab), which was approved June 1 to treat women with postmenopausal osteoporosis who are at high risk for fractures, also called skeletal-related events (SRE). The new indication would be for treatment of bone metastases to reduce SREs in patients with cancer.
Washington Drug Letter |
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