h breast or castrate-resistant prostate cancer (CRPC) with osseous metastases (Table 2). In patients with bone metastasis due to other solid tumors or lytic lesions due to multiple myeloma, Xgeva was noninferior to zoledronic acid in delaying the time to first SRE following randomization.
Overall survival and progression-free survival were similar between arms in all three trials. Mortality was higher with Xgeva in a subgroup analysis of patients with multiple myeloma (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180).
Table 2. Efficacy Results for Xgeva Compared to Zoledronic Acid
Trial 1 Metastatic Breast Cancer Trial 2 Metastatic Solid Tumors or Multiple Myeloma Trial 3 Metastatic CRPC CRPC = castrate-resistant prostate cancer.
Xgeva Zoledronic Acid Xgeva Zoledronic Acid Xgeva Zoledronic Acid
N 1026 1020 886 890 950 951
First On-study SRE
Number of Patients who had SREs (%) 315 (30.7) 372 (36.5) 278 (31.4) 323 (36.3) 341 (35.9) 386 (40.6)
Components of First SRE
Radiation to Bone 82 (8.0) 119 (11.7) 119 (13.4) 144 (16.2) 177 (18.6) 203 (21.3)
Pathological Fracture 212 (20.7) 238 (23.3) 122 (13.8) 139 (15.6) 137 (14.4) 143 (15.0)
Surgery to Bone 12 (1.2) 8 (0.8) 13 (1.5) 19 (2.1) 1 (0.1) 4 (0.4)
Spinal Cord Compression 9 (0.9) 7 (0.7) 24 (2.7) 21 (2.4) 26 (2.7) 36 (3.8)
Median Time to SRE (months) NR聽NR = not reached. 26.4 20.5 16.3 20.7 17.1
Hazard Ratio (95% CI) 0.82 (0.71, 0.95) 0.84 (0.71, 0.98) 0.82 (0.71, 0.95)
Noninferiority p-value < 0.001 < 0.001 < 0.001
Superiority p-valueSuperiority testing performed only after denosumab demonstrated to be noninferior to zoledronic acid within trial. 0.010 0.060 0.008
First and Subsequent SRE聽 All skeletal events postrandomization; new events defined by occurrence 鈮?21 days after preceding event.
Mean Number/Patient 0.46 0.60 0.44 0.49 0.52 0.61
Rate Ratio (95% CI) 0.77 (0.66, 0.89) 0.90 (0.77, 1.04) 0.82 (0.71, 0.94)
Superiority聽 p-valueAdjusted p-values are presented. 0.001 0.145 0.009
Xgeva is supplied in a single-use vial.
Store Xgeva in a refrigerator at 2掳C to 8掳C (36掳F to 46掳F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25掳C/77掳F or direct light and must be used within 14 days. Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.
Protect Xgeva from direct light and heat.
Avoid vigorous shaking of Xgeva.
120 mg/1.7 mL 1 vial per carton NDC 55513-730-01
Advise patients to contact a healthcare professional for any of the following:
Advise patients of the need for:
Advise patients that denosumab is also marketed as Prolia鈩? Patients should inform their healthcare provider if they are taking Prolia.
[Amgen Logo]
Xgeva鈩?(denosumab)
Manufactured by: Amgen Manufacturing Limited, a subsidiary of Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799
This produc
