骨转移用药狄诺塞麦国内上市了吗？

(denosumab) is an injectable drug with the chemical name denosumab, which is approved to prevent fractures caused by cancer that has spread to bones, not to prevent or delay the spread of cancer. Denosumab is seen as one of the most important growth drivers for Amgen, the world's largest biotech company. Today we will learn more about the bone metastasis drug denosumab on the market in China?

In 2018, denosumab (denosumab) injection was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the rapid review channel of the National Medical Products Administration. This approval makes denosumab (denosumab) the first and currently the only drug approved for the treatment of giant cell tumor of bone.

On May 27, 2019, denosumab (denosumab) was approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or where surgical resection may cause severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

Denosumab (denosumab) In a clinical trial of 1,432 men with prostate cancer that had stopped responding to hormone therapy, denosumab kept cancer cells from spreading to the bones for a little longer than four months. Amgen said denosumab will be able to treat 50,000 men in the United States whose disease has progressed to this stage.

Several international Phase III trials spanning three years and studying more than 12,000 postmenopausal women with osteoporosis or low bone mineral density (BMD), including studies in Asia, have shown that treatment with denosumab (denosumab) is effective and generally well tolerated. Compared with placebo, denosumab significantly reduced vertebral, non-vertebral and hip fractures and increased bone density throughout the body, including the lumbar spine and hip joints. In addition, an ongoing extension trial showed that the first-dose advantage of denosumab was significant and that this advantage was maintained during the subsequent 8 years of treatment. During the extension trial, denosumab was tolerable consistent with the initial 3-year FREEDOM trial.

At 12 months, denosumab (denosumab) treatment increased hip, lumbar spine, and/or femoral neck BMD and reduced bone turnover markers significantly more than oral bisphosphonates in women who were initially treated with bisphosphonates and who switched from alendronate to denosumab.

The above is the content of the launch of (denosumab), I hope it can help you!

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