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Bone cancer drug given priority review

Supported by data from 18 clinical trials, Amgen's denosumab has been given FDA priority review for bone cancer

The US Food and Drug Administration (FDA) has granted priority review to Amgen's denosumab to treat bone metastases in cancer patients. Bone metastases, most commonly associated with cancers of the prostate, lung and breast, can cause skeletal related events (SREs), such as fractures or spinal cord compression.

Denosumab, a subcutaneous RANK ligand inhibitor, is already approved for postmenopausal women with osteoporosis who are at high risk for fractures. Denosumab is the first compound to target the RANK/RANKL pathway, which is believed to play a crucial role in the bone destruction that cancer causes.

The development programme for denosumab is the largest Amgen has ever undertaken: over 11,000 patients have been enrolled in the trials in which the company is studying the compound in numerous tumour types across the spectrum of cancer-related bone diseases.

Dr Roger M Perlmutter, executive vice president of research and development at Amgen, said: "In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile. We believe that this priority review designation underscores the potential for denosumab to provide a meaningful advance over the current standard of care for patients with metastatic bone disease."

Amgen included data from 18 studies involving almost 7,000 patients to support the submission. As well as the submission to the FDA in the US, Amgen has also submitted denosumab for approval in the EU, Australia, Canada and Switzerland, and plans to submit for approval in Japan. According to the FDA's priority review guidelines of six months, the Biologics License Application (BLA), which was submitted in mid-May, must now be processed before November 18, 2010.

19th July 2010

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