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Regulator expands XGEVA’s indication for use by multiple myeloma patients
  • By Kim Yun-mi
  • Published 2019.03.04 16:02
  • Updated 2019.03.04 16:02
  • comments 0

Amgen’s XGEVA (denosumab), a treatment for reducing possibilities of skeletal complications in cancer patients with bone metastases, will be used by people with multiple myeloma, too, Amgen Korea said Monday.

The Ministry of Food and Drug Safety has recently approved expanded indication for XGEVA to treating patients with multiple myeloma and reducing the risks of skeletal-related events (SRE) in patients with bone metastases from solid tumors.

Amgen’s XGEVA Injection

The approval was based on data from the Phase 3 “482” study, a large international multiple myeloma clinical trial, which enrolled 1,718 patients.

The study met the primary endpoint, demonstrating non-inferiority of XGEVA to zoledronic acid in delaying the time to first on-study SRE in patients with multiple myeloma (p=0.01).

The acute phase adverse reaction occurrence rate was 5 percent in the XGEVA group and 9 percent in the zoledronic acid group. Also, kidney-related adverse reaction occurrence risk caused by treatment was 10 percent in the XGEVA group and 17 percent in the zoledronic acid group.l

The U.S. National Comprehensive Cancer Network (NCCN) recommends patients with multiple myeloma to take bisphosphonate or XGEVA and recommends XGEVA first for patients with kidney troubles.

Multiple myeloma is hematologic cancer which develops in plasma cells located in the bone marrow microenvironment. It is characterized by bone lesions and renal failure, and also can cause immune disorder and dyshematopoiesis Osteolytic lesions are confirmed in nine out of 10 patients diagnosed. Accordingly, chances are high skeletal-related events occur, such as pathologic fraction, irradiation on bones, spinal cord compression and bone surgery, in multiple myeloma patients.

SREs reduce the survival rate of multiple myeloma patients while increasing the financial burdens on patients and their families. Notably, patients with renal troubles, which account for about 60 percent of multiple myeloma patients, see their survival time decline further.

International guidelines recommend that patients with bone diseases who receive multiple myeloma treatment also to take bone-protecting treatment, but one-third of them fail to get such treatments.

“We are pleased to provide XGEVA in subcutaneous injection with clinical usefulness for patients with multiple myeloma patients in the nation with high possibilities of skeletal-related events,” Amgen Korea CEO Roh Sang-kyeong said. “Amgen Korea will continue to make efforts to fulfill unmet needs of more Korean patients in keeping with our mission statement of ‘To serve patients.’”


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