Xgeva is under clinical development by Amgen and currently in Phase II for Letterer-Siwe Disease (Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis). According to GlobalData, Phase II drugs for Letterer-Siwe Disease (Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Xgeva’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Xgeva overview

Denosumab (Xgeva / Ranmark / Corora) is a human monoclonal antibody of the immunoglobulin G2 (IgG2), acts as antineoplastic agent. It is produced in genetically engineered Chinese hamster ovary cells. It is formulated as solution, powder for solution for subcutaneous route of administration. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases in patients with multiple myeloma and giant cell tumor of bone. Xgeva is also indicated for the treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate, and for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months and is indicated for the treatment of adults and skeletally mature adolescents (defined as having at least one mature long bone and weigh≥45 kg) with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.

The drug candidate is under development for the treatment of nasopharyngeal cancer, multiple myeloma,  metastatic melanoma, langerhans cell histiocytosis (LCH), metastatic urothelial carcinoma and metastatic renal cell carcinoma. It was also under development for the treatment of breast cancer in Japan and metastatic breast cancer. (adjuvant therapy), bone metastasis.

It was also under development for the treatment of osteogenesis imperfecta and metastatic non-small cell lung cancer.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

For a complete picture of Xgeva’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.