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denosumab (Xgeva)

Advice

in the absence of a submission from the holder of the marketing authorisation: 

denosumab (Xgeva®) is not recommended for use within NHS Scotland. 

Indication: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. 

NICE (National Institute for Health and Clinical Excellence) is currently undertaking a multiple technology appraisal (MTA) that includes the use of denosumab in this indication.  However due to the significant time interval between product availability and the expected date of NICE guidance, not recommended advice has been issued.  The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication.  As a result we cannot recommend its use within NHSScotland.

Drug Details

Drug Name: denosumab (Xgeva)
SMC Drug ID: 752 /11
Manufacturer: Amgen Ltd
Indication: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
BNF Category:
Sub Category: 6.6 Drugs affecting bone metabolism
Submission Type: Non submission
Status: Not Recommended
Date Advice Published: 12 December 2011

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