UK's NICE takes second look at Amgen's Xgeva

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) today launched a second consultation on US biotech giant Amgen’s (Nasdaq: AMGN) Xgeva (denosumab), citing changes to draft recommendations concerning the drug as a treatment to prevent skeletal–related events in cancer patients whose disease has spread from a solid tumor site (eg, breast, prostate or lung) to their bones.

Carole Longson, director of the Centre for Health Technology Evaluation at the NICE, said: “Following a consultation on the first draft of this guidance, we received very helpful comments from clinical experts that shed new light on the original draft recommendations {The Pharma Letter March 30]. In particular, the consultation feedback provided the Appraisal Committee with more information on current UK clinical practice concerning the comparators in this appraisal. As a result, the committee reconsidered the evidence and revised the draft guidance. We are now welcoming comments from stakeholders on this revised draft.”

The NICE appraisal of denosumab as a treatment to delay or prevent skeletal-related events (such as pathological fractures, spinal cord compression, or radiation or surgery to the bone) in people with bone metastases from solid tumors is considering the drug as an alternative to a group of bone strengthening medicines called bisphosphonates (where they are prescribed in clinical practice) and as an alternative to best supportive care where bisphosphonates are not used.