Denosumab-bbdz

(Wyost®)

Wyost®

Drug updated on 10/17/2024

Dosage FormInjection (subcutaneous; 120 mg/1.7 mL [70 mg/mL])
Drug ClassRANK ligand (RANKL) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
  • Indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • Indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Latest News

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Summary
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  • This summary is based on the review of 22 systematic review(s)/meta-analysis(es). [1-20]
  • Hypercalcemia of Malignancy (HCM): Denosumab achieved non-inferiority to intravenous bisphosphonates in resolving hypercalcemia, with two-thirds of patients with refractory/recurrent HCM responding to denosumab after prior bisphosphonate therapy.
  • Multiple Myeloma (MM): Denosumab was non-inferior to zoledronic acid in overall survival, progression-free survival, and reducing skeletal-related events (SREs).
  • Giant Cell Tumor of Bone (GCTB): While denosumab was effective in long-term disease control, higher recurrence rates were observed post-curettage despite its use.
  • Bone Metastasis from Lung Cancer: Denosumab ranked higher than zoledronic acid for overall survival and time to first SRE (3) (HR (Hazard Ratio) = 0.86; 95% CI (Confidence Interval), 0.80-0.93; P = 0.0001), also reducing pathological fractures more effectively.
  • No significant difference in the adverse event rate was observed between denosumab and bisphosphonates in HCM patients.
  • Similar rates of osteonecrosis of the jaw (ONJ (RR (Relative Risk) 3.45, 95% CI 1.06 to 11.24; per 1000 participants 30 more (1 more to 125 more)) were reported for multiple myeloma patients treated with denosumab and zoledronic acid, while denosumab showed a better safety profile for renal toxicity.
  • Denosumab-treated patients with bone metastasis from lung cancer exhibited a higher incidence of hypocalcemia and ONJ compared to those treated with zoledronic acid, but had fewer cases of renal toxicity and acute phase reactions.
  • Denosumab is effective in specific populations, such as adults with refractory/recurrent hypercalcemia of malignancy (HCM) who did not respond to bisphosphonates, patients with multiple myeloma (MM), and patients with bone metastasis from lung or prostate cancer, showing similar or superior outcomes compared to bisphosphonates in terms of survival, progression, and skeletal-related events, though higher recurrence rates were observed in giant cell tumor of bone (GCTB) following curettage with denosumab.

Product Monograph / Prescribing Information

Document TitleYearSource
Wyost (denosumab-bbdz) Prescribing Information.2024 Sandoz Inc., Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Treatment of Hypercalcemia of Malignancy in Adults: An Endocrine Society Clinical Practice Guideline2023The Journal of Clinical Endocrinology & Metabolism
A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline on the Treatment of Hypercalcemia of Malignancy in Adults2023The Journal of Clinical Endocrinology & Metabolism
A systematic review and meta-analysis of interventional studies of bisphosphonates and denosumab in multiple myeloma and future perspectives2022Journal of Musculoskeletal and Neuronal Interactions
Surgical challenges, novel techniques, and systemic treatment of giant cell tumour of bone of the distal radius : clinical outcomes and systematic review of the literature2022Bone Joint Open
Unresectable Clival Giant Cell Tumor, Tumor Control With Denosumab After Relapse: A Case Report and Systematic Review of the Literature2022Journal of pediatric hematology/oncology
Current Status of Monoclonal Antibodies-Based Therapies in Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis of Clinical Trials2022Cureus
Evaluating the Optimal Management of Inoperable Giant Cell Tumors of the Spine: A Systematic Review and Meta-Analysis2022Cancers
Comparison of denosumab and zoledronic acid for the treatment of solid tumors and multiple myeloma with bone metastasis: a systematic review and meta-analysis based on randomized controlled trials2021Journal of Orthopaedic Surgery and Research
Multiprofessional Management of Giant Cell Tumors in the Cervical Spine: A Systematic Review2021World Neurosurgery
Which Bone-Modifying Agent is Associated with Better Outcomes in Patients with Skeletal Metastases from Lung Cancer? A Systematic Review and Network Meta-analysis2021Clinical Orthopaedics and Related Research
The Role of Denosumab for Surgical Outcomes in Patients with Giant Cell Tumour of Bone: A Systematic Review2021Current Oncology
Meta-analysis of clinical trials to assess denosumab over zoledronic acid in bone metastasis2021International Journal of Clinical Pharmacy
Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis2020The Cochrane Database of Systematic Reviews
Denosumab for Effective Tumor Size Reduction in Patients With Giant Cell Tumors of the Bone: A Systematic Review and Meta-Analysis2020Cancer control : Journal of the Moffitt Cancer Center
Bisphosphonates Versus Denosumab for Prevention of Pathological Fracture in Advanced Cancers With Bone Metastasis: A Meta-analysis of Randomized Controlled Trials2020Journal of the American Academy of Orthopaedic Surgeons
Denosumab Versus Zoledronic Acid in the Prevention of Skeletal-related Events in Vulnerable Cancer Patients: A Meta-analysis of Randomized, Controlled Trials2020Clinical Therapeutics
Bone modifying agents for bone loss in patients with aromatase inhibitor as adjuvant treatment for breast cancer; insights from a network meta-analysis2020Breast Cancer Research and Treatment
Pre-operative denosumab is associated with higher risk of local recurrence in giant cell tumor of bone: a systematic review and meta-analysis2020BMC Musculoskeletal Disorders
Atypical femoral fracture in patients with bone metastasis receiving denosumab therapy: a retrospective study and systematic review2019BMC Cancer
Denosumab treatment for giant-cell tumor of bone: a systematic review of the literature2019Archives of Orthopaedic and Trauma Surgery

Clinical Practice Guidelines