New Drugs Rx Option to Prevent Bone Complications in Men with Prostate Cancer
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Amgen has announced clinical trial success for its new drugs RX, XGEVA™ (Denosumab). The results are from the Phase 3 placebo trial, known as the ‘147 study', which involved 1,432 men diagnosed as castrate-resistant prostate cancer patients.
New Drugs Rx XGEVA Offers More Time to First Occurrence of Metastasis
Trial results showed that XGEVA improved bone metastasis-free survival by 4.2 months and significantly lengthened the time to first occurrence of the same. However, overall survival did not significantly differ for the placebo versus the XGEVA groups. Just as overall survival did not differ between the two groups, the overall rates of adverse events and serious adverse events also remained essentially the same between the two groups.
Essentially, the greatest finding of the study is that XGEVA limits the tumor’s ability to colonize bone, which means XGEVA delays bone destruction conditions, which then subsequently delays bone metastasis from moving forward. XGEVA makes the body’s environment less favorable to tumor growth.
On November 18, XGEVA was approved by the US Food and Drug Administration (FDA) for treatment in patients with bone metastases for prevention of skeletal-related events (SKEs) such as fractures and spinal cord compression. It should be noted that it is not approved for use in treatment of multiple myeloma. As such, according to medical experts, men with prostate cancer can use XGEVA to prevent serious bone complications. This particular drugs Rx does not require daily dosing - rather, use of this medication is accomplished with a single subcutaneous injection once every four weeks.
