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|Amgen Presents New Data From Phase 3 XGEVA® (denosumab) Study In Multiple Myeloma Patients At The 16th International Myeloma Workshop|
"Bone complications are devastating for patients with multiple myeloma. Renal function is a constant consideration in the treatment of multiple myeloma patients, often preventing the use of bisphosphonates, the only approved class of agents for prevention of bone complications, underscoring the need for new treatment options," said
The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met in this study. There was a suggested trend in overall survival (OS) in favor of XGEVA over zoledronic acid (HR=0.90, 95 percent CI: 0.70, 1.16; p=0.41); however, it was not statistically significant. The hazard ratio of XGEVA versus zoledronic acid for progression-free survival (PFS) was 0.82 (95 percent CI: 0.68, 0.99; descriptive p=0.036). The median PFS difference between arms was 10.7 months in favor of XGEVA.
"XGEVA is currently approved for the prevention of bone complications in patients with solid tumors based on superior clinical benefits over zoledronic acid in this setting," said
Adverse events observed in patients treated with XGEVA were consistent with the known safety profile of XGEVA. The most common adverse events (greater than 25 percent) were diarrhea (33.5 percent XGEVA and 32.4 percent zoledronic acid) and nausea (31.5 percent XGEVA and 30.4 percent zoledronic acid).
Multiple myeloma is the second most common hematologic cancer, and it develops in plasma cells located in the bone marrow microenvironment.1,2 Bone lesions appear in the vast majority of patients with multiple myeloma and weaken the bone.3 Myeloma cells induce RANK ligand (RANKL) expression, a protein essential for the formation, function and survival of osteoclasts, which break down bone. In addition, direct RANKL expression by myeloma cells may enhance osteoclast activity in the bone microenvironment.4 Excessive RANKL can increase the risk of bone complications, including pathologic fractures, radiation therapy or surgery to the bone, and spinal cord compression.5,6
About '482 Study (NCT01345019)
About Multiple Myeloma and Bone Complications
Bone lesions are a hallmark of multiple myeloma and often result in bone complications.3,6 Additionally, renal impairment is a common complication of multiple myeloma.8 Approximately 60 percent of all multiple myeloma patients have or will have renal impairment over the course of the disease.8 Current treatment options including zoledronic acid are cleared by the kidneys and associated with renal toxicity.6 Preventing bone complications is a critical aspect of caring for patients with multiple myeloma, because these events can cause significant morbidity.9
About XGEVA® (denosumab)
U.S. Important Safety Information
An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.
Drug Products with Same Active Ingredient
Osteonecrosis of the Jaw
Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a greater risk to develop ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroid, diabetes, and gingival infections.
Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA and periodically during XGEVA therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA. Consider temporarily interrupting XGEVA therapy if an invasive dental procedure must be performed.
Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA therapy should be considered, pending a risk/benefit assessment, on an individual basis.
The most common adverse reactions in patients receiving XGEVA for giant cell tumor of bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. The most common serious adverse reactions were osteonecrosis of the jaw and osteomyelitis. The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis of the jaw and tooth abscess or tooth infection.
The most common adverse reactions in patients receiving XGEVA for hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
Denosumab is also marketed as Prolia® in other indications.
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