Xtrenbo FDA Approval History
FDA Approved: Yes (First approved September 26, 2025)
Brand name: Xtrenbo
Generic name: denosumab-qbde
Dosage form: Injection
Company: Gedeon Richter plc and Hikma Pharmaceuticals plc
Xtrenbo (denosumab-qbde) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.
- Xtrenbo (denosumab-qbde) is indicated for:
- prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- 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.
- treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. - Xtrenbo is biosimilar to Xgeva and does not have an interchangeability designation.
- Xtrenbo is administered via subcutaneous injection.
- FDA approval was based on a comprehensive analytical, non-clinical, and clinical data package that demonstrated that Xtrenbo has similar quality, efficacy, safety and immunogenicity as the reference product Xgeva.
- Warnings and precautions associated with Xtrenbo include hypersensitivity reactions, hypocalcemia, osteonecrosis of the jaw, atypical femoral fracture, hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons, and multiple vertebral fractures following treatment discontinuation.
- Common adverse reactions
- Bone Metastasis from Solid Tumors: Common adverse reactions include fatigue/asthenia, hypophosphatemia, and nausea.
- Multiple Myeloma: Common adverse reactions include diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
- Giant Cell Tumor of Bone: Common adverse reactions include arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
- Hypercalcemia of Malignancy: Common adverse reactions include nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. - Xtrenbo is the seventh FDA-approved biosimilar to Xgeva.
Brand Name Generic Name Date of Approval Wyost denosumab-bbdz March 5, 2024 Xbryk denosumab-dssb February 13, 2025 Osenvelt denosumab-bmwo February 28, 2025 Bomyntra denosumab-bnht March 25, 2025 Bilprevda denosumab-nxxp August 29, 2025 Aukelso denosumab-kyqq September 16, 2025 Xtrenbo denosumab-qbde September 26, 2025 - Enoby (denosumab-qbde) was also approved on September 26, 2025 as the seventh biosimilar to Prolia (denosumab) after the approvals of Bosaya (denosumab-kyqq), Bildyos (denosumab-nxxp), Conexxence (denosumab-bnht), Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
Development timeline for Xtrenbo
| Date | Article |
|---|---|
| Sep 29, 2025 | Approval FDA Approves Xtrenbo (denosumab- qbde), a Biosimilar to Xgeva |
Further information
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