美国安进狄诺塞麦被获批用于骨巨细胞瘤的治疗

(Denosumab) is a drug produced by Amgen in the United States for the treatment of malignant tumors with bone metastasis. It is a human RANKL monoclonal antibody that binds to receptor activator of nuclear factor kB (RANK) with high affinity and specificity. Many previous large-scale phase III trials have shown that denosumab is significantly better than bisphosphonates in reducing bone destruction caused by various tumors and can also delay the occurrence of bone metastasis.

In a phase I clinical trial to verify the efficacy of denosumab in 35 patients with recurrent or refractory giant cell tumors of bone, the dosage of denosumab was 120 mg subcutaneous injection once every 4 weeks, with an additional dose on the 8th and 15th day of the first month; 30 of 35 cases (86%) had tumor response, and the giant cells with clear pathological findings on re-biopsy almost completely disappeared (all cases), and the condition was stable on imaging 6 months later (10 of 15 cases).

Although pain or quality of life were not assessed in this confirmatory study, the data still showed that 26 of 35 patients had pain relief or improved function, and 9 had radiographic bone repair. After 4 weeks of medication, fluorodeoxyglucose-positron emission computed tomography (FDG-PET) showed rapid changes in metabolic uptake, indicating a therapeutic response. Bone metabolism inhibition, including a decrease in urinary N-terminal peptide and blood C-terminal peptide, appeared as early as 28 days after taking the drug, and continued throughout the entire study.

Denosumab treatment was well tolerated, with no treatment-related serious adverse reactions. This study shows that denosumab can block the RANKL signaling pathway in patients with relapsed or refractory giant cell tumors of bone, resulting in significant changes in tumor composition and reduced bone destruction, showing clinical effectiveness.

Since entering China in 2012, Amgen has always taken serving patients as its mission, based on science and biotechnology, and is committed to benefiting Chinese patients and improving public health. The efficacy of its research and development and production is quite obvious.

Recommended hot articles: /newsDetail/87459.html