Amgen’s Statement in Response to Sheffield Telegraph Story on Denosumab
Below is Amgen’s statement in response to a Sheffield Telegraph story about a coroner’s inquest held on April 17 in Sheffield, England, to determine the cause of death of an advanced prostate cancer patient who was part of a denosumab clinical trial evaluating treatment of bone metastases. A coroner decides when it is appropriate to conduct an inquest to determine the cause of an individual’s death.
“Amgen expresses sympathy to the family for their loss. In more than 19,000 patients worldwide, denosumab is being evaluated for its potential to treat and prevent bone loss and destruction across a range of conditions. In completed clinical trials, there have been no deaths attributed to denosumab. On April 14 a panel of independent physician experts reviewed the safety data for nearly 8,000 patients involved in ongoing denosumab oncology studies – which included this case – and did not indicate any concerns. This expert panel recommended that all denosumab oncology studies continue without change.
Acute respiratory distress syndrome (ARDS) is a condition that sometimes develops in advanced cancer patients. It is therefore to be expected that some cases will occur in patients enrolled in the denosumab oncology program.
We have no record of any other patients in any denosumab study receiving upper hemi-body radiation (systemic radiation to the whole upper body, including the lungs), and therefore we view this case as unique. Other radiation treatments (not hemi-body) are frequently used to treat advanced cancer and bone metastases in the denosumab oncology program. The frequency of use of radiation to control bony metastases is recorded as one of the primary outcomes of the study, including radiation to the spine and ribs. No interaction between denosumab and this radiation has been reported to date.
As with any serious adverse event, Amgen has followed the appropriate procedures and notified regulatory agencies in compliance with safety reporting obligations. In addition, all serious adverse events, including deaths on study, have been routinely reported to investigators who are responsible in turn to inform their patients.
We have noted the findings of the coroner: multiple factors may have had a role in the death of this seriously ill cancer patient, including the cancer itself, the administration of denosumab, pulmonary emboli and hemi-body radiation. From Amgen’s perspective, there is no clinical or pre-clinical evidence at this time that denosumab use is associated with adverse events in the lungs. Amgen believes denosumab has a positive safety profile, with the potential to benefit many patients.”
For more information:
Lisa Rooney: (805) 559-0739 (media)
