XGEVA
Xgeva is an approved remedy to treat hypercalcemia that appears with growth of malignant neoplasms , which is refractory to treatment with bisphosphonates.
Also Xgeva according to the use indications has been assigned with the orphan status.
The drug is treats of giant bone cell tumor. This benign tumor osteoclastoma diagnosed in 20% of all benign tumors. It appears the malady in people aged 20 to 40 years. The pathology is localized more often in long bones. Main number of cases occurs in the epiphyses and epimetaphysis tibia and femur. Excessive growth of tumors in these segments, as well as the untimely extended treatment can lead to inoperable forms of the disease, when the removal of the bone must be removed joints or limbs. Therefore, scientists are studying the mechanisms of this disease in order to create an effective drug formula.
It managed the company «Amgen». The drug Xgeva acts directly on bone tissue. By linking the protein RANKL, allows the drug to maintain bone tissue in a healthy condition. Besides the drug in clinical trials has established itself as an effective remedy for inoperable stage osteoclastoma. In 2010, the FDA approved the use of the drug as a prophylactic to prevent fractures in patients with advanced non-malignant tumors in the bone. After successful studies, the application of the company to expand the range of use of the drug has received priority review status.
To register a new indication for the use of the drug have been conducted additional clinical studies involving 350 people. The group were patients with recurrent or unresectable osteoclastoma, as well as those for whom surgery would have serious complications. A clinical study showed that after 3 months of taking the drug tumor decreased in size in 25.1% of patients.
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